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Improving Emotion Regulation at the End of Breast Cancer Treatment

Primary Purpose

Breast Cancer, Emotional Disturbances, Emotional Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive-Behavioral Group Therapy and Hypnosis
Cognitive-Behavioral Group Therapy and Hypnosis
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Emotion Regulation, Post-Treatment Breast Cancer Care, Cognitive-Behavioral Therapy, CBT, Hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Experiencing moderate to high emotion dysregulation (one to four scores = or > 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts)
  • Non-metastatic breast cancer
  • Post chimiotherapy, radiotherapy, surgery treatment
  • Age > 18 years
  • Completing a written informed consent

Exclusion Criteria:

  • Male
  • Non-fluency in French
  • Severe cognitive impairment
  • Severe and/or acute psychiatric disorder.

Sites / Locations

  • Institut Jules Bordet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Experimental Group

Waiting-List Control Group

Arm Description

Patients include in the experimental group (EG) will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will resort to usual care only after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).

Patients include in the waiting-list control group (CG) will resort to usual care only after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).

Outcomes

Primary Outcome Measures

Change in Patients' Subjective Emotion Regulation through six 10-cm visual analog scales assessing anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels
Change in patients' subjective emotion regulation will be examined using the Emotion Regulation Task. Patients are asked to self-report their anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels just after both exposures to anxiety triggers (the Mental Adjustment to Cancer Scale (MAC)) and the Impact of Cancer questionnaire Version 2 (IOCv2)) and regulation exercises (self-relaxation and induced relaxation) using six 10-cm visual analog scales (VAS; with the extreme left defined as "not at all" and the extreme right defined as "extremely"). VAS are used because such scales have been shown to be appropriate and adequate for the assessment of emotional states (Davey et al., 2007; Wewers & Lowe, 1990).
Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute)
Change in patients' objective emotion regulation will be examined using the Emotion Regulation Task. Heart rate (beats per minute) is measured throughout the Emotion Regulation Task using an ambulatory digital Holter recorder.
Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment
Change in patients' emotion regulation in their everyday life will be assessed through an ecological momentary assessment (EMA) procedure during 7 days. The EMA procedure will allow to observe the evolution of the ratio between positive and negative emotions in patients' everyday life (Fredrickson & Losada, 2005).
Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ)
Change in patients' emotional state will be assessed in terms of anxiety: Anxiety is assessed by the Hospital Anxiety Depression Scale (HADS) - anxiety 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder. Anxiety is also assessed by the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry.
Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)
Change in patients' emotional state will be assessed in terms of depression: Depression is assessed by the Hospital Anxiety Depression Scale - depression 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder.
Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI)
Change in patients' emotional state will be assessed in terms of fear of cancer recurrence: Fear of cancer recurrence is assessed by the Fear of Cancer Recurrence Inventory (FCRI). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.

Secondary Outcome Measures

Change in an adapted Emotion Symptom Assessment Scale (ESAS)
Patients will complete a self-report adapted Emotion Symptom Assessment Scale (ESAS) assessing from 0 to 10 their usual emotional and symptomatic states (i.e., pain, physical fatigue, psychological fatigue, sleeping difficulties, memory disorder, concentration disorder, feeling of discomfort, hot flushes, depression, anxiety, fear of cancer recurrence, and ruminations).
Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire
Patients will complete the Hospital Anxiety and Depression Scale (HADS) - anxiety and depression 14-item ordinal self-report subscales (Zigmond & Snaith, 1983). Each item is scored from 0 to 3. The total score ranges from 0 to 42. A total score from 0 to 12 is considered as normal, from 13 to 18 as an adaptation disorder, and from 19 to 42 as a mood disorder.
Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire
Patients will complete the Fear of Cancer Recurrence Inventory (FCRI) (Simard & Savard, 2009). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.
Change in the White Bear Suppression Inventory (WBSI)
Patients will complete the White Bear Suppression Inventory (WBSI) (Schmidt et al., 2009 ; Wegner & Zanakos, 1994). The WBSI is a 15-item ordinal self-report measure of thought suppression. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater tendencies to suppress thoughts.
Change in the Mental Adjustment to Cancer Scale (MAC)
Patients will complete the Mental Adjustment to Cancer Scale (MAC) (Watson et al., 1988). The MAC is a 40-item ordinal self-report ordinal measure of five psychological dimensions of mental adjustment in cancer patients (fighting spirit, anxious preoccupation, helpless-hopelessness, fatalism, and avoidance). Each item is scored from 1 (definitely does not apply to me) to 4 (definitely applies to me).
Change in Penn State Worry Questionnaire (PSWQ)
Patients will complete the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry.
Change in the Five Facet of Mindfulness Questionnaire (FFMQ)
Patients will complete the Five Facet of Mindfulness Questionnaire (FFMQ) (Baer et al., 2008). The FFMQ is 39-item ordinal self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Each item is scored from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating more mindfulness.
Change in the Metacognitions About Health Anxiety Questionnaire (MCQ-30)
Patients will complete the Metacognitions About Health Anxiety Questionnaire (MCQ-30) (Wells & Cartwright-Hatton, 2004). The MCQ-30 is a 30-item self-report measure of metacognitive beliefs (beliefs about thinking). The MCQ-30 have five subscales: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about the need to control thoughts. Each item is scored from 1 (do not agree) to 4 (agree very much). Subscale scores range from 6 to 24, and total scores range from 30 to 120, with higher scores indicating higher levels of unhelpful metacognitions.
Change in the Insomnia Severity Index (ISI)
Patients will complete the Insomnia Severity Index (ISI) (Morin et al., 2011). The ISI is a brief 7-item self-report measure of insomnia. A total score from 0 to 7 is considered as no clinically significant insomnia, from 8 to 14 as a subthreshold insomnia, from 15 to 21 as a moderate clinical insomnia, and from 22 to 28 as a severe clinical insomnia.
Change in the Impact of Cancer Scale (IOCv2)
Patients will complete the Impact of Cancer Scale (IOCv2) (Zebrack et al., 2006). The IOCv2 is a 37-item self-report measure of the quality of life of long-term cancer survivorship. The IOCv2 consists of two higher-order scales, a Positive Impact Scale and a Negative Impact Scale, each with four subscales: Altruism and empathy, health awareness, meaning of cancer, and positive self-evaluation subscales for the Positive Impact Scale, and appearance concerns, body change concerns, life interferences, and worry subscales for the Negative Impact Scale. The IOCv2 also have three additional subscales measuring employment and relationship impacts. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). A higher score on a subscale/scale implies stronger endorsement of that content area.
Change in the Cognitive Emotion Regulation Questionnaire (CERQ)
Patients will complete the Cognitive Emotion Regulation Questionnaire (CERQ) (Jermann et al., 2006). The CERQ is a 36-item self-report measure of cognitive emotion regulation strategies someone uses after having experienced negative events or situations. The CERQ distinguishes 9 cognitive coping strategie: Self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophizing, and other-blame. Each item is scored from 1 ((almost) never) to 5 (always). The higher the score on a subscale, the more the patient uses this cognitive coping strategy.
Change in the Multidimensional Fatigue Inventory (MFI-20)
Patients will complete the Multidimensional Fatigue Inventory (MFI-20) (Smets et al., 1995). The MFI-20 is a 20-item self-report measure of fatigue which covers the five following dimensions: General fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating greater fatigue.
Change in a Life Event Questionnaire
Patients will complete a life event questionnaire assessing hours of physical activity practice, hours of sleep, drugs use, cafeine, theine and alcohol intake, psychogical background, and health care use.
Change in Ecological Momentary Assessment through the use of a pedometer and a measure of cardio frequency (Garmin vívoactive® HR)
Patients are provided with an armband (Garmin vívoactive® HR) to continuously record during nine days (two days of test and seven days of assessment), their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns.
Change in Attentional Bias through a dot probe task
The attentional dot probe computer task will provide a dynamic picture of patients' attentional orientation.

Full Information

First Posted
August 4, 2017
Last Updated
December 7, 2020
Sponsor
Université Libre de Bruxelles
Collaborators
Jules Bordet Institute, Centre de Psycho-Oncologie (CPO)
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1. Study Identification

Unique Protocol Identification Number
NCT03336827
Brief Title
Improving Emotion Regulation at the End of Breast Cancer Treatment
Official Title
Improving Emotion Regulation at the End of Breast Cancer Treatment: A Randomized Controlled Study Assessing the Impact of a Multi-Component Psychological Group Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles
Collaborators
Jules Bordet Institute, Centre de Psycho-Oncologie (CPO)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The end of treatment marks the beginning of a challenging period for breast cancer patients. While this period often provokes a sense of relief, it can also be a source of apprehension and vulnerability regarding the future. Patients may be brought to feel contradictory thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty and fear of cancer recurrence. In order to accompany breast cancer patients during this transition period and to address these emotional difficulties, the Institut Jules Bordet has launched an 8-session psychological multi-component group intervention. Its objective is to bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts, learning to cope with uncertainty, attention reorientation toward positive thoughts) to promote emotion management and well-being.
Detailed Description
Introduction At the end of treatment, breast cancer patients are confronted with the short- and long-term physical (e.g., fatigue, pain, hot flashes) and psychological (e.g., anxiety, fear of recurrence, depressive symptoms) consequences of cancer diagnosis and treatment (Costanzo et al., 2007 ; Stanton et al., 2005). Emotion dysregulation (e.g., anxiety, fear of recurrence (Devine & Westlake,1995), depressive symptoms (Stanton, 2006)) is, with fatigue (Jacobsen & Jim, 2008) and cognitive dysfunctions (Duijts et al., 2011), one of the three most common complaints. Nevertheless, few psychological interventions have focused on this period (Jacobsen & Jim, 2008 ; Stanton et al., 2005 ; Stanton, 2006) and no intervention has specifically addressed emotion regulation of breast cancer survivors (Devine & Westlake, 1995 ; Duijts et al., 2011 ; Sheard & Maguire, 1999). Little is known about the required components of psychological interventions designed to support patients facing these challenges. Meta-analyses (Naaman et al., 2009 ; Osborn, 2006 ; Sheard & Maguire, 1999) and one review (Traeger et al., 2012) have described various components of interventions used to address anxiety and depressive symptoms in cancer care, such as mindfulness (Lengacher et al., 2009 ; Würtzen et al., 2013), education (Björneklett et al., 2012 ; Dolbeault et al., 2009 ; Duijts et al., 2011 ; Fors et al., 2011 ; Osborn, 2006 ; Scheier et al., 2005), cognitive-behavioral therapy (Dolbeault et al., 2009 ; Duijts et al., 2012 ; Fors et al., 2011 ; Osborn, 2006 ; Savard et al., 2005 ; Savard et al., 2005), support groups (Björneklett et al., 2012 ; Fors et al., 2011 ; Montazeri et al., 2001), and relaxation training (Björneklett et al., 2012 ; Elsesser, Van Berkel & Sartory, 1994 ; Hidderley & Holt, 2004). These interventions taken individually presented moderate effect sizes (Naaman et al., 2009), suggesting the need to combine components. During the last four years, our team conducted a study designed to compare the benefits in terms of emotion regulation of a 15-session single-component group intervention (SGI) based only on support with those of a 15-session multi-component group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. The cognitive-behavioral therapy (CBT) components were chosen because interventions using such components have shown larger effect sizes than interventions using other components in previous studies on the treatment of anxiety-related conditions (Chambless & Ollendick, 2001 ; Deacon & Abramowitz, 2004 ; Norton & Price, 2007 ; Osborn, 2006 ; Stewart & Chambless, 2009). The hypnosis component was chosen because some reviews have suggested that self-hypnosis training is a rapid, cost-effective, and safe alternative to medication for the treatment of such conditions. Moreover, a meta-analysis showed that the addition of hypnosis to cognitive-behavioral component enhances effect sizes of interventions (Kirsch, Montgomery & Sapirstein, 1995) . Results of this study have shown the acceptability of such an intervention after active treatment (Merckaert et al., 2015). They have also indicated that an MGI combining support with CBT and hypnosis is clinically useful for patients with breast cancer after radiotherapy. Our results confirm the need to design specific interventions targeting anxiety regulation, fear of recurrence, and depressive symptoms. They also underline the necessity of intensifying interventions through including other components (e.g., emotion regulation, repetitive exposures to fear, treatment of intrusive thoughts, attention reorientation). Objectives of the study The primary aims of this study are to evaluate in a randomized controlled trial (RCT) the efficacy of an 8-session multi-component group intervention extended over 4 months in promoting emotion regulation (in an emotion regulation task and in everyday life) and patient emotional well-being compared with a waiting-list control group. The secondary aims are to evaluate patients' satisfaction with the program, hypnosis/relaxation practice in everyday life, mental adjustment, and changes in patients' level of attentional bias toward cancer threat and physical activity. Participants Patients who have been treated for a non-metastatic breast cancer will be approached at the end of active cancer treatment (i.e., surgery, chemotherapy, and radiotherapy) in order to be screened for emotion dysregulation. Patients experiencing moderate to high emotion dysregulation (one to four scores = or > 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts) will be offered the intervention. Intervention 4.1. Theoretical framework This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component. 4.1.1. The emotion regulation component builds upon the Adaptive Coping with Emotions Model which was developed to provide a conceptualization of adaptive emotion regulation. It aims to help patients to better identify their physical, emotional and behavioral responses to their positive and negative emotions in order to be able to better regulate or acknowledge those emotions. This component integrates a self-regulation component. The self-regulation component relies on a phone app-based coaching intervention aiming at promoting changes in patients' ability to regulate their emotions in their everyday life. It aims at promoting patients' self-awareness of their internal states, orientating their attention consciously toward positive stimuli and at developing physical activity. Hypnosis is used as hetero-hypnosis in each session and aims at deepening the development of patients' emotion regulation skills. Recordings of the exercises done in session are transmitted to the patients in order to promote use of the technique at home. Helping patients develop autohypnosis skills is important as it may allow them to better regulate their emotions in everyday life. 4.1.2. The exposure to fear component aims at helping patients deal with their fear of death. Just as anxiety is a normal emotion, anxiety concerning death is also a normal experience. The modest level of death anxiety that most people experience in everyday life may increase dramatically when one experiences a period of health problems, illness, or death of someone close (Kastenbaum, 2000). This part of the intervention will be based on worry exposure. This part of the intervention targets cancer-related worry and is based on Borkovec's avoidance theory of worry (Borkovec et al., 1998). Worry is a predominantly cognitive-verbal activity that inhibits full emotional processing. As a result, disturbing emotional meanings of potentially dangerous and anxiously anticipated events cannot be fully tested or altered, making the repetitive processing of the feared stimuli probable (Foa & Kozak, 1986). Given that cancer-recurrence related-worry is typically characterized by the focus on one hypothetical future event, it follows that exposure with imagined stimuli could be a crucial component of the treatment of fear of recurrence. The intervention will be based on two exercises. In the first, patients will be accompanied through a hypnosis based exposure to a major trigger of fear of recurrence that is the anticipation of the cancer check-up. This exercise is designed to help patients experience the emotions which may arise in this context while being guided through their resolution and regulation. The second exercise aims at helping them overcome their fear of recurrence through discussing their worst-case scenario in the group. The scenario are then discussed in order to highlight which part of them could be modified because it is unrealistic or because patients have more resources than they anticipate. 4.2. Study design and assessment schedule This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG). 4.2.1. Pre-assessment screening Before inclusion in the study, during the last weeks of treatment (T0), approached patients will complete a socio-demographic questionnaire, a screening of life habits and difficulties questionnaire, an adapted Edmonton symptom evaluation scale (Chang, Hwang & Feuerman, 2000) (assessing pain, fatigue, sleep disturbances, fatigue, difficulty concentrating, memory loss, feeling of malaise, hot flashes, depression, anxiety, fear of recurrence, and worry), the Hospital anxiety and depression scale (HADS) (Zigmond & Snaith, 1983), and the Fear of Cancer Recurrence Inventory Severity sub-scale (Simard & Savard, 2009). Patients will report medical information about their disease, previous and current treatment and prognosis. This screening allows checking for inclusion and exclusion criteria and comparing patients who accept and refuse the intervention. 4.2.2. Assessment procedure Each assessment procedure (i.e., T1, T2, T3) includes three parts: an emotion regulation task, an ecological momentary assessment and an attentional bias task. Two months after T1 and T2, the experimental (EG) and control (CG) groups will be contacted once by phone to complete a phone-based questionnaire to assess their usual care use. 4.2.2.1. Emotion regulation task This assessment procedure has been used in a previous project and provides a dynamic picture of patients' emotion regulation. Each assessment session will first involve completion of questionnaires and two emotion regulation exercises: (1) 4 min exposure to anxiety triggers through completion of the Mental Adjustment to Cancer Scale (Watson et al., 1988), followed by a 12-min self-relaxation exercise in which patients will be asked to relax by using their own strategies; and (2) 4 min exposure to anxiety triggers through completion of the Impact of Cancer Questionnaire (Zebrack et al., 2006), followed by a 12-min guided hypnosis exercise in which patients will be asked to listen to an audio recording of a hypnotic induction script. The subtasks will be separated by a period of questionnaires completion. Patients' emotion regulation will be measured physiologically (heart rate measurement) and psychologically (anxiety, sadness, fear of recurrence and energy state-levels). 4.2.2.2. Ecological momentary assessment (EMA) Patients' emotion regulation in their everyday life will be assessed during 9 days through an ecological momentary assessment (EMA) procedure. Firstly, patients will be asked 5 times a day to select on a list of 20 emotions the 2 or 3 that they were experiencing during the minutes before they saw the notification. For each emotion experienced, they will have to report its intensity on a 10-point Likert scale ranging from 1 to 10. They will have to report to what extent they have felt able to control those emotions and have felt submerged by those emotions. They will report whether during those minutes they had been thinking about something other than what they were currently doing. They will have to answer with one of four options: no; yes, something pleasant; yes, something neutral; or yes, something unpleasant (Killingsworth & Gilbert, 2010). Finally, they will be asked their level of fatigue and energy. Prompts will be sent randomly from 9 AM to 7,5 PM through the use of the software from http://www.lifedatacorp.com/. Secondly, each evening for 9 consecutive days, patients will have to indicate on the same list of 20 emotions (10 positive and 10 negative emotions), the extent to which they have felt each of the 20 emotions in the past 24 hours and their level of fatigue, from 0 (not at all) to 4 (extremely) (Fredrickson et al., 2003). In order to insure confidentiality, subjects will be provided with an iPod Touch. The two first days of data collection will be used as a training for participants and only their responses on the 7 following days will be taken into consideration. Thirdly, patients will be provided with an armband to continuously record during those 9 days, their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns (Garmin vívoactive HR). 4.2.2.3. Attentional bias task Patients will complete an attentional bias computer task assessing attentional orientation toward emotional information. An adaptive function of biased attentional orientation toward negative information is to facilitate detection of danger in the environment and to help the organism respond effectively to threatening situations (Bar-Haim et al., 2007). When anxiety symptoms become excessive, biased attentional orientation toward negative information may have detrimental effects on patients' cognitive (e.g., intrusive thoughts, misinterpretation), behavioral (e.g., body screening, future planning difficulties), emotional (e.g., negative affects, panic attacks), and physiological status (e.g., physiological stress activation), and may play a prominent role in the etiology and maintenance of anxiety disorders (Bar-Haim et al., 2007). Computer tasks have been used to study the threat-related attentional bias in anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Emotional Disturbances, Emotional Dysfunction, Anxiety Depression, Fear of Cancer
Keywords
Emotion Regulation, Post-Treatment Breast Cancer Care, Cognitive-Behavioral Therapy, CBT, Hypnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate in the study will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Other
Arm Description
Patients include in the experimental group (EG) will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will resort to usual care only after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).
Arm Title
Waiting-List Control Group
Arm Type
Other
Arm Description
Patients include in the waiting-list control group (CG) will resort to usual care only after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Group Therapy and Hypnosis
Intervention Description
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Group Therapy and Hypnosis
Intervention Description
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Primary Outcome Measure Information:
Title
Change in Patients' Subjective Emotion Regulation through six 10-cm visual analog scales assessing anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels
Description
Change in patients' subjective emotion regulation will be examined using the Emotion Regulation Task. Patients are asked to self-report their anxiety, sadness, fear of cancer recurrence, physical fatigue, psychological fatigue, and energy state-levels just after both exposures to anxiety triggers (the Mental Adjustment to Cancer Scale (MAC)) and the Impact of Cancer questionnaire Version 2 (IOCv2)) and regulation exercises (self-relaxation and induced relaxation) using six 10-cm visual analog scales (VAS; with the extreme left defined as "not at all" and the extreme right defined as "extremely"). VAS are used because such scales have been shown to be appropriate and adequate for the assessment of emotional states (Davey et al., 2007; Wewers & Lowe, 1990).
Time Frame
Change from T1 (baseline) Patients' Subjective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Patients' Subjective Emotion Regulation at T3 (4 months after T2) for the CG
Title
Change in Patients' Objective Emotion Regulation through an ambulatory digital Holter recording heart rate (beats per minute)
Description
Change in patients' objective emotion regulation will be examined using the Emotion Regulation Task. Heart rate (beats per minute) is measured throughout the Emotion Regulation Task using an ambulatory digital Holter recorder.
Time Frame
Change from T1 (baseline) Patients' Objective Emotion Regulation at T2 (4 months after T1) and maintenance at T3 (4 monts after T2) for the EG; Change from T2 Patients' Objective Emotion Regulation at T3 (4 monts after T2) for the CG
Title
Change in Patients' Emotion Regulation in their Everyday Life through an ecological momentary assessment
Description
Change in patients' emotion regulation in their everyday life will be assessed through an ecological momentary assessment (EMA) procedure during 7 days. The EMA procedure will allow to observe the evolution of the ratio between positive and negative emotions in patients' everyday life (Fredrickson & Losada, 2005).
Time Frame
Change from T1 (baseline) Emotion Regulation in their Everyday Life at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Emotion Regulation in their Everyday Life at T3 (4 months after T2) for the CG
Title
Change in Patients' Anxiety State through the Hospital Anxiety Depression Scale (HADS) - anxiety subscale and the Penn State Worry Questionnaire (PSWQ)
Description
Change in patients' emotional state will be assessed in terms of anxiety: Anxiety is assessed by the Hospital Anxiety Depression Scale (HADS) - anxiety 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder. Anxiety is also assessed by the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry.
Time Frame
Change from T1 (baseline) Anxiety State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Anxiety State at T3 (4 months after T2) for the CG
Title
Change in Patients' Depression State through the Hospital Anxiety Depression Scale (HADS)
Description
Change in patients' emotional state will be assessed in terms of depression: Depression is assessed by the Hospital Anxiety Depression Scale - depression 7-item ordinal self-report subscale (Duijts et al., 2012 ; Naaman et al., 2009). Each item is scored from 0 to 3. The subscale score ranges from 0 to 21. A subscale score from 0 to 7 is considered as normal, from 8 to 10 as an adaptation disorder, and from 11 to 21 as a mood disorder.
Time Frame
Change from T1 (baseline) Depression State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Depression State at T3 (4 months after T2) for the CG
Title
Change in Patients' Fear of Cancer Recurrence State through the Fear of Cancer Recurrence Inventory (FCRI)
Description
Change in patients' emotional state will be assessed in terms of fear of cancer recurrence: Fear of cancer recurrence is assessed by the Fear of Cancer Recurrence Inventory (FCRI). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.
Time Frame
Change from T1 (baseline) Fear of Cancer Recurrence State at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Fear of Cancer Recurrence State at T3 (4 months after T2) for the CG
Secondary Outcome Measure Information:
Title
Change in an adapted Emotion Symptom Assessment Scale (ESAS)
Description
Patients will complete a self-report adapted Emotion Symptom Assessment Scale (ESAS) assessing from 0 to 10 their usual emotional and symptomatic states (i.e., pain, physical fatigue, psychological fatigue, sleeping difficulties, memory disorder, concentration disorder, feeling of discomfort, hot flushes, depression, anxiety, fear of cancer recurrence, and ruminations).
Time Frame
Change from T1 (baseline) ESAS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ESAS at T3 (4 months after T2) for the CG
Title
Change in the Hospital Anxiety and Depression Scale (HADS) Questionnaire
Description
Patients will complete the Hospital Anxiety and Depression Scale (HADS) - anxiety and depression 14-item ordinal self-report subscales (Zigmond & Snaith, 1983). Each item is scored from 0 to 3. The total score ranges from 0 to 42. A total score from 0 to 12 is considered as normal, from 13 to 18 as an adaptation disorder, and from 19 to 42 as a mood disorder.
Time Frame
Change from T1 (baseline) HADS at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 HADS at T3 (4 months after T2) for the CG
Title
Change in the Fear of Cancer Recurrence Inventory (FCRI) Questionnaire
Description
Patients will complete the Fear of Cancer Recurrence Inventory (FCRI) (Simard & Savard, 2009). It is a 42-item 5-point ordinal self-report scale including seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance (Simard & Savard, 2009). A higher score indicates higher levels of fear of cancer recurrence.
Time Frame
Change from T1 (baseline) FCRI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FCRI at T3 (4 months after T2) for the CG
Title
Change in the White Bear Suppression Inventory (WBSI)
Description
Patients will complete the White Bear Suppression Inventory (WBSI) (Schmidt et al., 2009 ; Wegner & Zanakos, 1994). The WBSI is a 15-item ordinal self-report measure of thought suppression. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater tendencies to suppress thoughts.
Time Frame
Change from T1 (baseline) WBSI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 WBSI at T3 (4 months after T2) for the CG
Title
Change in the Mental Adjustment to Cancer Scale (MAC)
Description
Patients will complete the Mental Adjustment to Cancer Scale (MAC) (Watson et al., 1988). The MAC is a 40-item ordinal self-report ordinal measure of five psychological dimensions of mental adjustment in cancer patients (fighting spirit, anxious preoccupation, helpless-hopelessness, fatalism, and avoidance). Each item is scored from 1 (definitely does not apply to me) to 4 (definitely applies to me).
Time Frame
Change from T1 (baseline) MAC at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MAC at T3 (4 months after T2) for the CG
Title
Change in Penn State Worry Questionnaire (PSWQ)
Description
Patients will complete the 16-item ordinal self-report Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990). Each item is scored from 1 ("not at all typical of me") to 5 ("very typical of me"). The total scale score ranges from 16 to 80, with higher scores reflecting greater levels of pathological worry.
Time Frame
Change from T1 (baseline) PSWQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 PSWQ at T3 (4 months after T2) for the CG
Title
Change in the Five Facet of Mindfulness Questionnaire (FFMQ)
Description
Patients will complete the Five Facet of Mindfulness Questionnaire (FFMQ) (Baer et al., 2008). The FFMQ is 39-item ordinal self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Each item is scored from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating more mindfulness.
Time Frame
Change from T1 (baseline) FFMQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 FFMQ at T3 (4 months after T2) for the CG
Title
Change in the Metacognitions About Health Anxiety Questionnaire (MCQ-30)
Description
Patients will complete the Metacognitions About Health Anxiety Questionnaire (MCQ-30) (Wells & Cartwright-Hatton, 2004). The MCQ-30 is a 30-item self-report measure of metacognitive beliefs (beliefs about thinking). The MCQ-30 have five subscales: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about the need to control thoughts. Each item is scored from 1 (do not agree) to 4 (agree very much). Subscale scores range from 6 to 24, and total scores range from 30 to 120, with higher scores indicating higher levels of unhelpful metacognitions.
Time Frame
Change from T1 (baseline) MCQ-30 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MCQ-30 at T3 (4 months after T2) for the CG
Title
Change in the Insomnia Severity Index (ISI)
Description
Patients will complete the Insomnia Severity Index (ISI) (Morin et al., 2011). The ISI is a brief 7-item self-report measure of insomnia. A total score from 0 to 7 is considered as no clinically significant insomnia, from 8 to 14 as a subthreshold insomnia, from 15 to 21 as a moderate clinical insomnia, and from 22 to 28 as a severe clinical insomnia.
Time Frame
Change from T1 (baseline) ISI at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 ISI at T3 (4 months after T2) for the CG
Title
Change in the Impact of Cancer Scale (IOCv2)
Description
Patients will complete the Impact of Cancer Scale (IOCv2) (Zebrack et al., 2006). The IOCv2 is a 37-item self-report measure of the quality of life of long-term cancer survivorship. The IOCv2 consists of two higher-order scales, a Positive Impact Scale and a Negative Impact Scale, each with four subscales: Altruism and empathy, health awareness, meaning of cancer, and positive self-evaluation subscales for the Positive Impact Scale, and appearance concerns, body change concerns, life interferences, and worry subscales for the Negative Impact Scale. The IOCv2 also have three additional subscales measuring employment and relationship impacts. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). A higher score on a subscale/scale implies stronger endorsement of that content area.
Time Frame
Change from T1 (baseline) IOCv2 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 IOCv2 at T3 (4 months after T2) for the CG
Title
Change in the Cognitive Emotion Regulation Questionnaire (CERQ)
Description
Patients will complete the Cognitive Emotion Regulation Questionnaire (CERQ) (Jermann et al., 2006). The CERQ is a 36-item self-report measure of cognitive emotion regulation strategies someone uses after having experienced negative events or situations. The CERQ distinguishes 9 cognitive coping strategie: Self-blame, acceptance, rumination, positive refocusing, refocus on planning, positive reappraisal, putting into perspective, catastrophizing, and other-blame. Each item is scored from 1 ((almost) never) to 5 (always). The higher the score on a subscale, the more the patient uses this cognitive coping strategy.
Time Frame
Change from T1 (baseline) CERQ at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 CERQ at T3 (4 months after T2) for the CG
Title
Change in the Multidimensional Fatigue Inventory (MFI-20)
Description
Patients will complete the Multidimensional Fatigue Inventory (MFI-20) (Smets et al., 1995). The MFI-20 is a 20-item self-report measure of fatigue which covers the five following dimensions: General fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating greater fatigue.
Time Frame
Change from T1 (baseline) MFI-20 at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 MFI-20 at T3 (4 months after T2) for the CG
Title
Change in a Life Event Questionnaire
Description
Patients will complete a life event questionnaire assessing hours of physical activity practice, hours of sleep, drugs use, cafeine, theine and alcohol intake, psychogical background, and health care use.
Time Frame
Change from T1 (baseline) Life Event Questionnaire at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Life Event Questionnaire at T3 (4 months after T2) for the CG
Title
Change in Ecological Momentary Assessment through the use of a pedometer and a measure of cardio frequency (Garmin vívoactive® HR)
Description
Patients are provided with an armband (Garmin vívoactive® HR) to continuously record during nine days (two days of test and seven days of assessment), their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns.
Time Frame
Change from T1 (baseline) Heart Rate, Physical Activiy and Sleep Patterns at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Ecological Momentary Assessment at T3 (4 months after T2) for the CG
Title
Change in Attentional Bias through a dot probe task
Description
The attentional dot probe computer task will provide a dynamic picture of patients' attentional orientation.
Time Frame
Change from T1 (baseline) Attentional Bias at T2 (4 months after T1) and maintenance at T3 (4 months after T2) for the EG; Change from T2 Attentional Bias at T3 (4 months after T2) for the CG

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Experiencing moderate to high emotion dysregulation (one to four scores = or > 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts) Non-metastatic breast cancer Post chimiotherapy, radiotherapy, surgery treatment Age > 18 years Completing a written informed consent Exclusion Criteria: Male Non-fluency in French Severe cognitive impairment Severe and/or acute psychiatric disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darius Razavi, Prof
Organizational Affiliation
Université Libre de Bruxelles, Institut Jules Bordet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Merckaert, Prof
Organizational Affiliation
Université Libre de Bruxelles, Institut Jules Bordet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18000503
Citation
Costanzo ES, Lutgendorf SK, Mattes ML, Trehan S, Robinson CB, Tewfik F, Roman SL. Adjusting to life after treatment: distress and quality of life following treatment for breast cancer. Br J Cancer. 2007 Dec 17;97(12):1625-31. doi: 10.1038/sj.bjc.6604091. Epub 2007 Nov 13.
Results Reference
background
PubMed Identifier
16247779
Citation
Stanton AL, Ganz PA, Rowland JH, Meyerowitz BE, Krupnick JL, Sears SR. Promoting adjustment after treatment for cancer. Cancer. 2005 Dec 1;104(11 Suppl):2608-13. doi: 10.1002/cncr.21246.
Results Reference
background
PubMed Identifier
8539178
Citation
Devine EC, Westlake SK. The effects of psychoeducational care provided to adults with cancer: meta-analysis of 116 studies. Oncol Nurs Forum. 1995 Oct;22(9):1369-81.
Results Reference
background
PubMed Identifier
17093275
Citation
Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775.
Results Reference
background
PubMed Identifier
18558664
Citation
Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16.
Results Reference
background
PubMed Identifier
20336645
Citation
Duijts SF, Faber MM, Oldenburg HS, van Beurden M, Aaronson NK. Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors--a meta-analysis. Psychooncology. 2011 Feb;20(2):115-26. doi: 10.1002/pon.1728.
Results Reference
background
PubMed Identifier
10468295
Citation
Sheard T, Maguire P. The effect of psychological interventions on anxiety and depression in cancer patients: results of two meta-analyses. Br J Cancer. 1999 Aug;80(11):1770-80. doi: 10.1038/sj.bjc.6690596.
Results Reference
background
PubMed Identifier
11163418
Citation
Lang PJ, Davis M, Ohman A. Fear and anxiety: animal models and human cognitive psychophysiology. J Affect Disord. 2000 Dec;61(3):137-59. doi: 10.1016/s0165-0327(00)00343-8.
Results Reference
background
PubMed Identifier
11044347
Citation
Stark DP, House A. Anxiety in cancer patients. Br J Cancer. 2000 Nov;83(10):1261-7. doi: 10.1054/bjoc.2000.1405.
Results Reference
background
PubMed Identifier
22412135
Citation
Traeger L, Greer JA, Fernandez-Robles C, Temel JS, Pirl WF. Evidence-based treatment of anxiety in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1197-205. doi: 10.1200/JCO.2011.39.5632. Epub 2012 Mar 12.
Results Reference
background
PubMed Identifier
17201568
Citation
Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IJzendoorn MH. Threat-related attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull. 2007 Jan;133(1):1-24. doi: 10.1037/0033-2909.133.1.1.
Results Reference
background
PubMed Identifier
19322661
Citation
Lebel S, Rosberger Z, Edgar L, Devins GM. Emotional distress impacts fear of the future among breast cancer survivors not the reverse. J Cancer Surviv. 2009 Jun;3(2):117-27. doi: 10.1007/s11764-009-0082-5. Epub 2009 Mar 26.
Results Reference
background
PubMed Identifier
19027440
Citation
Llewellyn CD, Weinman J, McGurk M, Humphris G. Can we predict which head and neck cancer survivors develop fears of recurrence? J Psychosom Res. 2008 Dec;65(6):525-32. doi: 10.1016/j.jpsychores.2008.03.014. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
16258929
Citation
Baker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488.
Results Reference
background
PubMed Identifier
19884548
Citation
Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients' supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009 Dec 20;27(36):6172-9. doi: 10.1200/JCO.2009.22.5151. Epub 2009 Nov 2.
Results Reference
background
PubMed Identifier
21519023
Citation
Harrison SE, Watson EK, Ward AM, Khan NF, Turner D, Adams E, Forman D, Roche MF, Rose PW. Primary health and supportive care needs of long-term cancer survivors: a questionnaire survey. J Clin Oncol. 2011 May 20;29(15):2091-8. doi: 10.1200/JCO.2010.32.5167. Epub 2011 Apr 25.
Results Reference
background
PubMed Identifier
10618627
Citation
Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P. The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer. 2000 Jan 1;88(1):226-37. doi: 10.1002/(sici)1097-0142(20000101)88:13.3.co;2-g.
Results Reference
background
PubMed Identifier
20042336
Citation
Hopwood P, Sumo G, Mills J, Haviland J, Bliss JM; START Trials Management Group. The course of anxiety and depression over 5 years of follow-up and risk factors in women with early breast cancer: results from the UK Standardisation of Radiotherapy Trials (START). Breast. 2010 Apr;19(2):84-91. doi: 10.1016/j.breast.2009.11.007. Epub 2009 Dec 29.
Results Reference
background
PubMed Identifier
17719358
Citation
Lebel S, Rosberger Z, Edgar L, Devins GM. Comparison of four common stressors across the breast cancer trajectory. J Psychosom Res. 2007 Sep;63(3):225-32. doi: 10.1016/j.jpsychores.2007.02.002. Epub 2007 Aug 2.
Results Reference
background
PubMed Identifier
9540167
Citation
Visser MR, Smets EM. Fatigue, depression and quality of life in cancer patients: how are they related? Support Care Cancer. 1998 Mar;6(2):101-8. doi: 10.1007/s005200050142.
Results Reference
background
PubMed Identifier
10904452
Citation
DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.
Results Reference
background
PubMed Identifier
17640330
Citation
Falagas ME, Zarkadoulia EA, Ioannidou EN, Peppas G, Christodoulou C, Rafailidis PI. The effect of psychosocial factors on breast cancer outcome: a systematic review. Breast Cancer Res. 2007;9(4):R44. doi: 10.1186/bcr1744.
Results Reference
background
PubMed Identifier
21923569
Citation
Bjorneklett HG, Lindemalm C, Rosenblad A, Ojutkangas ML, Letocha H, Strang P, Bergkvist L. A randomised controlled trial of support group intervention after breast cancer treatment: results on anxiety and depression. Acta Oncol. 2012 Feb;51(2):198-207. doi: 10.3109/0284186X.2011.610352. Epub 2011 Sep 19.
Results Reference
background
PubMed Identifier
19366294
Citation
Naaman SC, Radwan K, Fergusson D, Johnson S. Status of psychological trials in breast cancer patients: a report of three meta-analyses. Psychiatry. 2009 Spring;72(1):50-69. doi: 10.1521/psyc.2009.72.1.50.
Results Reference
background
PubMed Identifier
16927576
Citation
Osborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatry Med. 2006;36(1):13-34. doi: 10.2190/EUFN-RV1K-Y3TR-FK0L.
Results Reference
background
PubMed Identifier
19235193
Citation
Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.
Results Reference
background
PubMed Identifier
23265707
Citation
Wurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.
Results Reference
background
PubMed Identifier
19039808
Citation
Dolbeault S, Cayrou S, Bredart A, Viala AL, Desclaux B, Saltel P, Gauvain-Piquard A, Hardy P, Dickes P. The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study. Psychooncology. 2009 Jun;18(6):647-56. doi: 10.1002/pon.1440.
Results Reference
background
PubMed Identifier
15994143
Citation
Scheier MF, Helgeson VS, Schulz R, Colvin S, Berga S, Bridges MW, Knapp J, Gerszten K, Pappert WS. Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. J Clin Oncol. 2005 Jul 1;23(19):4298-311. doi: 10.1200/JCO.2005.05.362.
Results Reference
background
PubMed Identifier
20821803
Citation
Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6.
Results Reference
background
PubMed Identifier
23045575
Citation
Duijts SF, van Beurden M, Oldenburg HS, Hunter MS, Kieffer JM, Stuiver MM, Gerritsma MA, Menke-Pluymers MB, Plaisier PW, Rijna H, Lopes Cardozo AM, Timmers G, van der Meij S, van der Veen H, Bijker N, de Widt-Levert LM, Geenen MM, Heuff G, van Dulken EJ, Boven E, Aaronson NK. Efficacy of cognitive behavioral therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: results of a randomized, controlled, multicenter trial. J Clin Oncol. 2012 Nov 20;30(33):4124-33. doi: 10.1200/JCO.2012.41.8525. Epub 2012 Oct 8.
Results Reference
background
PubMed Identifier
16135475
Citation
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. doi: 10.1200/JCO.2005.09.548.
Results Reference
background
PubMed Identifier
16135476
Citation
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part II: Immunologic effects. J Clin Oncol. 2005 Sep 1;23(25):6097-106. doi: 10.1200/JCO.2005.12.513.
Results Reference
background
PubMed Identifier
11722855
Citation
Montazeri A, Jarvandi S, Haghighat S, Vahdani M, Sajadian A, Ebrahimi M, Haji-Mahmoodi M. Anxiety and depression in breast cancer patients before and after participation in a cancer support group. Patient Educ Couns. 2001 Dec 1;45(3):195-8. doi: 10.1016/s0738-3991(01)00121-5.
Results Reference
background
Citation
Elsesser, K., Van Berkel, M., & Sartory, G. (1994). The effects of anxiety management training on psychological variables and immune parameters in cancer patients. Behavioural and Cognitive Psychotherapy, 22, 13-23.
Results Reference
background
PubMed Identifier
15003745
Citation
Hidderley M, Holt M. A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses. Eur J Oncol Nurs. 2004 Mar;8(1):61-5. doi: 10.1016/j.ejon.2003.09.003.
Results Reference
background
PubMed Identifier
18492319
Citation
Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.
Results Reference
background
PubMed Identifier
24756313
Citation
Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23.
Results Reference
background
PubMed Identifier
15712339
Citation
Mishel MH, Germino BB, Gil KM, Belyea M, Laney IC, Stewart J, Porter L, Clayton M. Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005 Nov;14(11):962-78. doi: 10.1002/pon.909.
Results Reference
background
PubMed Identifier
23475398
Citation
Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.
Results Reference
background
PubMed Identifier
19865833
Citation
Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G. Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Cancer. 2010 Apr;18(4):471-9. doi: 10.1007/s00520-009-0696-1. Epub 2009 Oct 29.
Results Reference
background
PubMed Identifier
11148322
Citation
Chambless DL, Ollendick TH. Empirically supported psychological interventions: controversies and evidence. Annu Rev Psychol. 2001;52:685-716. doi: 10.1146/annurev.psych.52.1.685.
Results Reference
background
PubMed Identifier
15022272
Citation
Deacon BJ, Abramowitz JS. Cognitive and behavioral treatments for anxiety disorders: a review of meta-analytic findings. J Clin Psychol. 2004 Apr;60(4):429-41. doi: 10.1002/jclp.10255.
Results Reference
background
PubMed Identifier
17568301
Citation
Norton PJ, Price EC. A meta-analytic review of adult cognitive-behavioral treatment outcome across the anxiety disorders. J Nerv Ment Dis. 2007 Jun;195(6):521-31. doi: 10.1097/01.nmd.0000253843.70149.9a.
Results Reference
background
PubMed Identifier
19634954
Citation
Stewart RE, Chambless DL. Cognitive-behavioral therapy for adult anxiety disorders in clinical practice: a meta-analysis of effectiveness studies. J Consult Clin Psychol. 2009 Aug;77(4):595-606. doi: 10.1037/a0016032.
Results Reference
background
PubMed Identifier
20136382
Citation
Hammond DC. Hypnosis in the treatment of anxiety- and stress-related disorders. Expert Rev Neurother. 2010 Feb;10(2):263-73. doi: 10.1586/ern.09.140.
Results Reference
background
PubMed Identifier
7751482
Citation
Kirsch I, Montgomery G, Sapirstein G. Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis. J Consult Clin Psychol. 1995 Apr;63(2):214-20. doi: 10.1037//0022-006x.63.2.214.
Results Reference
background
PubMed Identifier
27718533
Citation
Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Lienard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7.
Results Reference
background
Citation
Berking, M., & Schwarz, J. (2013). Affect regulation training. Handbook of Emotion Regulation. New York: Guilford.
Results Reference
background
Citation
Kastenbaum, R. (2000). The psychology of death (3rd ed.). New York: Springer.
Results Reference
background
Citation
Borkovec, T.D., et al. (1998). Worry: a cognitive phenomenon intimately linked to affective, physiological, and interpersonal behavioral processes. Cognitive Therapy and Research, 22(6), 561-576.
Results Reference
background
PubMed Identifier
2871574
Citation
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
Results Reference
background
Citation
Merckaert, I., et al. (2016). Emotion regulation at the beginning of the survivorship period for breast cancer: Comparing the impact of an 8-session to a 15-session multicomponent group intervention, submitted abstract. Psychooncology.
Results Reference
background
PubMed Identifier
10813730
Citation
Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.
Results Reference
background
PubMed Identifier
18414902
Citation
Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.
Results Reference
background
PubMed Identifier
3363039
Citation
Watson M, Greer S, Young J, Inayat Q, Burgess C, Robertson B. Development of a questionnaire measure of adjustment to cancer: the MAC scale. Psychol Med. 1988 Feb;18(1):203-9. doi: 10.1017/s0033291700002026.
Results Reference
background
PubMed Identifier
16097041
Citation
Zebrack BJ, Ganz PA, Bernaards CA, Petersen L, Abraham L. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006 May;15(5):407-21. doi: 10.1002/pon.963.
Results Reference
background
PubMed Identifier
21071660
Citation
Killingsworth MA, Gilbert DT. A wandering mind is an unhappy mind. Science. 2010 Nov 12;330(6006):932. doi: 10.1126/science.1192439.
Results Reference
background
PubMed Identifier
16221001
Citation
Fredrickson BL, Losada MF. Positive affect and the complex dynamics of human flourishing. Am Psychol. 2005 Oct;60(7):678-86. doi: 10.1037/0003-066X.60.7.678. Erratum In: Am Psychol. 2013 Dec;68(9):822.
Results Reference
background
Citation
Zelenski, J. M., & Larsen, R. J. (2000). The Distribution of Basic Emotions in Everyday Life: A State and Trait Perspective from Experience Sampling Data. Journal of Research in Personality, 34(2), 178-197.
Results Reference
background
PubMed Identifier
11315248
Citation
Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.
Results Reference
background
PubMed Identifier
2076086
Citation
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
Results Reference
background
PubMed Identifier
18509902
Citation
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
Results Reference
background
PubMed Identifier
17346609
Citation
Davey HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007 Apr;60(4):356-60. doi: 10.1016/j.jclinepi.2006.07.015. Epub 2006 Dec 27.
Results Reference
background
PubMed Identifier
8484338
Citation
Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J. 1993 Mar;13(1):15-24.
Results Reference
background
PubMed Identifier
2197679
Citation
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Results Reference
background
PubMed Identifier
17069959
Citation
Friedman BH. An autonomic flexibility-neurovisceral integration model of anxiety and cardiac vagal tone. Biol Psychol. 2007 Feb;74(2):185-99. doi: 10.1016/j.biopsycho.2005.08.009. Epub 2006 Oct 27.
Results Reference
background
PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
background
PubMed Identifier
20017061
Citation
Schmidt RE, Gay P, Courvoisier D, Jermann F, Ceschi G, David M, Brinkmann K, Van der Linden M. Anatomy of the White Bear Suppression Inventory (WBSI): a review of previous findings and a new approach. J Pers Assess. 2009 Jul;91(4):323-30. doi: 10.1080/00223890902935738.
Results Reference
background
PubMed Identifier
18310597
Citation
Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
Results Reference
background
PubMed Identifier
14998733
Citation
Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5.
Results Reference
background
PubMed Identifier
21532953
Citation
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Results Reference
background
Citation
Jermann, F., et al. (2006). Cognitive Emotion Regulation Questionnaire (CERQ): Confirmatory Factor Analysis and Psychometric Properties of the French Translation. European Journal of Psychological Assessment, 22, 126-131.
Results Reference
background
PubMed Identifier
7636775
Citation
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
Results Reference
background
PubMed Identifier
15209195
Citation
Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study design
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http://pdf.lu/YtWd
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List of questionnaires
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http://pdf.lu/TJ4c
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Informed Consent Form
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http://pdf.lu/dN2P
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Informed Consent Form
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http://pdf.lu/07Xz

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Improving Emotion Regulation at the End of Breast Cancer Treatment

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