Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive-behavioral therapy and hypnosis group
Support group
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring patients at the end of treatment
Eligibility Criteria
Inclusion Criteria:
- Non-metastatic breast cancer (in situ or invesive)
- End of active treatments (surgery, chemotherapy and radiotherapy)
- No recurrence nor palliative care
- Min. 18 years
- Able to speak French
- Willing to be randomized to study intervention group
- Accept to give their written informed consent
Exclusion Criteria:
- No cognitive dysfunction
- No severe or uncontrolled psychiatric illness
Sites / Locations
- Institut Jules Bordet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-behavioral therapy and hypnosis group
Support group
Arm Description
Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.
Patients will receive (in groups of 6) fifteen 120-min support group session.
Outcomes
Primary Outcome Measures
Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)
Questionnaires:
Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23"
Edmonton symptom evaluation scale
Way of life questionnaire
Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...
Questionnaires:
the Hospital Anxiety and Depression Scale
the Rosenberg's Self-Esteem
the Mental Adjustment to Cancer Scale
the Fear of Cancer Recurrence Inventory
the Perceived Social Support Questionnaire
the Courtauld Emotional Control scale
the Ways of Coping Checklist
the Toronto Alexithymia Scale
a questionnaire about usual emotional state
a questionnaire about the use of relaxation techniques and self-hypnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT01797354
First Posted
December 28, 2011
Last Updated
September 3, 2015
Sponsor
Université Libre de Bruxelles
Collaborators
Jules Bordet Institute
1. Study Identification
Unique Protocol Identification Number
NCT01797354
Brief Title
Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Official Title
Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles
Collaborators
Jules Bordet Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.
Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.
Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
patients at the end of treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral therapy and hypnosis group
Arm Type
Experimental
Arm Description
Patients will receive (in groups of 6) fifteen 120-min sessions of group therapy including cognitive-behavioral techniques and hypnosis.
Arm Title
Support group
Arm Type
Active Comparator
Arm Description
Patients will receive (in groups of 6) fifteen 120-min support group session.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy and hypnosis group
Intervention Type
Behavioral
Intervention Name(s)
Support group
Primary Outcome Measure Information:
Title
Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)
Description
Questionnaires:
Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23"
Edmonton symptom evaluation scale
Way of life questionnaire
Time Frame
Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)
Title
Psychological wellbeing: emotional state, emotional adjustment, social adjustment, quality of life,...
Description
Questionnaires:
the Hospital Anxiety and Depression Scale
the Rosenberg's Self-Esteem
the Mental Adjustment to Cancer Scale
the Fear of Cancer Recurrence Inventory
the Perceived Social Support Questionnaire
the Courtauld Emotional Control scale
the Ways of Coping Checklist
the Toronto Alexithymia Scale
a questionnaire about usual emotional state
a questionnaire about the use of relaxation techniques and self-hypnosis
Time Frame
Change from baseline in emotional state, emotional adjustment, social adjustment and quality of life at 6 (T1) and 12 (T2) months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-metastatic breast cancer (in situ or invesive)
End of active treatments (surgery, chemotherapy and radiotherapy)
No recurrence nor palliative care
Min. 18 years
Able to speak French
Willing to be randomized to study intervention group
Accept to give their written informed consent
Exclusion Criteria:
No cognitive dysfunction
No severe or uncontrolled psychiatric illness
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
Citations:
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
derived
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Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
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