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Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

Primary Purpose

Advanced or Metastatic Cancer, Fear of Cancer Progression, Metacognition-based Intervention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ConquerFear intervention
CALM intervention
Basic Cancer Care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Cancer

Eligibility Criteria

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

Inclusion Criteria: Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer are the age of 18 years or above Exclusion Criteria: Patients with major communication difficulties are being unwilling or unable to commit 6 psychotherapy sessions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    ConquerFear intervention

    CALM intervention

    Basic Cancer Care

    Arm Description

    Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

    Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.

    Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.

    Outcomes

    Primary Outcome Measures

    Fear of Progression
    The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.

    Secondary Outcome Measures

    Metacognitions
    The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.
    Depression
    Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.
    Death anxiety
    Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.

    Full Information

    First Posted
    December 19, 2022
    Last Updated
    June 30, 2023
    Sponsor
    The University of Hong Kong
    Collaborators
    Research Grants Council, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05679518
    Brief Title
    Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches
    Official Title
    Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    Research Grants Council, Hong Kong

    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 present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.
    Detailed Description
    A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer. The aims are to test: the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition. Primary hypothesis: Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced or Metastatic Cancer, Fear of Cancer Progression, Metacognition-based Intervention, Supportive-expressive Based Intervention, Psychooncology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The investigators will use a block randomization structure with randomly permuted block sizes of 3 and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or CALM or control arms. The participants are masked in terms of not knowing that the interventions (i.e. Conquer fear and CALM) are hypothesized to yield larger effects than the other (i.e. control).
    Allocation
    Randomized
    Enrollment
    261 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ConquerFear intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.
    Arm Title
    CALM intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.
    Arm Title
    Basic Cancer Care
    Arm Type
    Active Comparator
    Arm Description
    Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ConquerFear intervention
    Intervention Description
    ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CALM intervention
    Intervention Description
    CALM is a semi-structured, manualized, individual psychotherapy intervention designed for patients with advanced cancer. It includes 3-6 individual therapy sessions, with each approximately lasts 45-60 minutes, delivered over 3-6 months. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patient, but the sequencing and time devoted to each domain can be varied, based on the concerns that are most relevant to each patient.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Basic Cancer Care
    Intervention Description
    Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.
    Primary Outcome Measure Information:
    Title
    Fear of Progression
    Description
    The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.
    Time Frame
    Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
    Secondary Outcome Measure Information:
    Title
    Metacognitions
    Description
    The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.
    Time Frame
    Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
    Title
    Depression
    Description
    Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.
    Time Frame
    Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
    Title
    Death anxiety
    Description
    Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.
    Time Frame
    Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with advanced or metastatic (i.e. stage III or IV) cancer are the age of 18 years or above Exclusion Criteria: Patients with major communication difficulties are being unwilling or unable to commit 6 psychotherapy sessions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Danielle Wing Lam Ng, PhD
    Phone
    +852 39179897
    Email
    dwlng@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy Wing Tak Lam, PhD
    Organizational Affiliation
    School of Public Health, The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD that underlie results in a publication will be available from the PI upon reasonable request.
    IPD Sharing Time Frame
    Starting 6 months after publication
    IPD Sharing Access Criteria
    Information will be available from the PI upon reasonable request. The author to review requests is the PI.

    Learn more about this trial

    Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

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