The goal of this clinical trial is to determine whether an adapted version of a current cognitive-behavioural group therapy (CBT) protocol for cancer survivors to the specific needs of women who are carriers of the BRCA1/2 genetic mutation will reduce their levels of fear of cancer recurrence. The main questions this study aims to answer are:

* Will the women who have received the adapted CBT be satisfied with it?
* Will there be a significant difference in the women's fear of cancer recurrence and other variables (e.g., depression, anxiety, insomnia, fatigue, quality of life) between the comparison groups?
* Will the effects of the adapted CBT hold over time?
* What are the roles of different etiological mediating variables in the relationship between fear of cancer recurrence and the effects of the adapted CBT on the severity of fear of cancer recurrence?

Researchers will compare the effects of the adapted CBT between the immediate condition and the waitlist condition.

Participants will be:

* Either placed in the immediate condition or the waitlist condition (the participants in the waitlist condition will begin their therapy once the immediate group is done with theirs).
* Taking part in a group CBT session online once a week for eleven weeks.
* Completing questionnaires pre-intervention, post-intervention, 3 months post-intervention, and 6 months post-intervention.

Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene

Breast Cancer Susceptibility Gene (BRCA1) Mutation

BRCA2 Mutation

Fear of Cancer Recurrence

Research Problem:

Fear of cancer recurrence (FCR) is defined as fear, worry or concern about the possibility that cancer may recur or progress. FCR is among the top three least-satisfied needs of cancer patients. Almost all patients will experience FCR at some point in their care trajectory. While many will experience occasional and easily managed FCR, mainly at the time of medical testing, others will experience severe and persistent FCR if no intervention is offered. However, it is only in the last two decades that researchers have begun to study FCR in greater depth. Although there is no universally accepted definition and criteria yet, it has been estimated that 45% to 55% of patients have clinical or moderate/severe levels of FCR. Furthermore, longitudinal studies have shown that FCR tends to remain stable over time, particularly among those with clinical levels. FCR is associated with psychological disorders such as anxiety and depression, and reduced quality of life. People experiencing FCR are also more likely to consult healthcare professionals and to use psychotropic drugs such as anxiolytics and antidepressants.

Given the high prevalence and persistence of FCR and its possible consequences, it seems essential, from both an individual and societal point of view, to offer effective psychological interventions to patients with high FCR. Several programs have been developed and tested, with promising results. To our knowledge, our program is the only one internationally to have been implemented in routine oncology care. This program is a group cognitive-behavioral therapy (CBT) of 4 sessions of about 2 hours, whose efficacy has been confirmed in an uncontrolled study (pre- vs. post-treatment). Our treatment protocol and materials, combining therapist and participant manuals, have recently been published in English. The program is integrated into routine cancer care at two hospitals of the Quebec region.

A subpopulation of cancer patients that has been overlooked in the FCR literature is those at high risk of recurrence due to a genetic mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer, and at a younger age. They also have a greater risk of cancer recurrence (or a second cancer). Women with a BRCA1/2 mutation are particularly vulnerable to high and persistent levels of FCR, that prophylactic surgery is by no means sufficient to eliminate FCR, and that a cost-effective psychological intervention specifically targeting FCR should ideally be offered as a complement to current practices and counseling offered to these patients. A qualitative study confirmed that FCR is a significant problem in these women and that they emphasized the need to develop and provide access to FCR interventions tailored to the needs of BRCA1/2 mutation carriers. Among other things, they mentioned their particular needs in relation to their younger age and greater risk of cancer recurrence, and raised several issues specific to them, such as having to decide whether to give birth to a child, as pregnancy can increase the risk of recurrence for these women, and the fear of leaving their children motherless should the cancer recur. As for the type of support they would need, they spontaneously mentioned the relevance of group sessions to enable them to share their personal experiences with other women going through the same difficulties. This suggests that a group psychotherapy targeting FCR, adapted to the needs of this specific population, should be developed and tested.

Method:

The adaptation of the treatment manual will be carried out iteratively, using a Delphi method and a series of recorded meetings. As a first step, committee members will be asked to familiarize themselves on an individual basis with the content of a number of existing treatment manuals, including that of Savard et al. (2022), and with the results of the qualitative study by Savard et al. (2024) conducted among women treated for breast cancer and carrying a BRCA1/2 genetic mutation. An initial meeting will be held to pool the adaptation ideas that each member will have gained from reading the documents. Then, the research team will list all the possible modifications identified, and compile a questionnaire evaluating the importance and relevance of each possible adaptation on a Likert-type scale ranging from "0" (not at all) to "5" (very pertinent), with open-ended comments on each. The newly developed questionnaire will be sent individually to the members of the expert comittee and the research team will compile the data obtained and present it to the same panel of experts at a second meeting in the form of graphs (i.e., percentage endorsement of each answer choice) and lists (for open-ended comments).The expert committee will make a selection in order to eliminate or modify the adaptations least well endorsed and those generating the most questions. The research team will compile a second version of the questionnaire with the possible additions retained. It will be administered to the same expert committee to assess the relevance/importance of each remaining modification option. If necessary, a third round of evaluation using the same procedure will be carried out. The research team will be responsible for making adaptations to both the Therapist's Manual and the Participant's Manual. These will be resubmitted to the expert committee for comment and final approval. If necessary, an additional meeting will be held.

Participants will be recruited by referral from healthcare professionals working in oncology and oncogenetics, and through advertisements placed in various media across Quebec (posters in waiting rooms, flyers, social media, etc.). Women interested in participating in the study should contact the study coordinator by e-mail or telephone. This will be followed by a telephone interview to assess the main eligibility criteria. The eligible participants will be asked to complete the consent form.

A randomization list will be generated by a statistician blind to the study's objectives, hypotheses and procedures. Once the required number of eligible participants to form a group (n = ~ 5-8) has been reached, the group will be randomized to : 1) immediate CBT-FCR-BRCA1/2; or 2) waiting list condition on a 1:1 ratio. The participants will be informed, via their preferred method of communication by the project's coordinator, of their assigned group and the procedure for the next steps according to group.

Participants assigned to the immediate CBT-FCR-BRCA1/2 group will receive 7 weekly group intervention sessions, while those assigned to the control condition will wait for 7 weeks and complete the same battery of questionnaires (post-attendance measurement) again before receiving the intervention in turn. The sessions will last 90 min each and will be led by two facilitators, one of whom will be a psychologist specialized in oncology. To increase the feasibility of the project, facilitate the participation of women who are often young, mothers of young children and on the job market, and to be able to offer the intervention to women with a BRCA1/2 genetic mutation from all over Quebec, the sessions will be offered by videoconference (e.g. Zoom). The psychologist chosen to administer the intervention has already received training in CBT for general FCR and is already offering it in her current practice. She will be assisted by another psychologist or intern/trainee in psycho-oncology. For the purposes of this project, both practitioners will receive one-day training on the medical and psychological aspects of hereditary cancers and on adaptations to the FCR treatment protocol. A pilot study will initially be led following the same procedures (N = ~ 50 participants) in order to evaluate the feasibility of this RCT.

Cognitive-behavioral group therapy

The questionnaire includes 38 questions and assess seven aspects associated with fear of cancer recurrence: Triggers, Severity, Psychological Distress, Functioning impairments, Insight, Reassurance and Coping Strategies. Total values vary between 0 and 152. Higher scores indicate a greater fear of recurrence.

Researcher

Includes a total of 14 questions: 7 for anxiety and 7 for depression. For both aspects, the maximum score possible is 21. A score between 0 and 7 indicates a normal level of symptoms, a score between 8 and 10 indicates a borderline abnormal level of symptoms and a score between 11 and 21 indicates an abnormal level of symptoms.

Includes a total of 7 items. Total score varies between 0 and 28. A score between 0 and 7 indicates no clinically significant insomnia, a score between 8 and 14 indicates subthreshold insomnia, a score between 15 and 21 indicates moderate insomnia (moderate severity) and a score between 22 and 28 indicates clinical insomnia (severe).

Includes a total of 7 items. Total score varies between 0 and 70. Lower scores indicate lower levels of fatigue and higher scores indicate higher levels of fatigue.

30-items questionnaire developed to assess the quality of life of all cancer patients. Scores range from 0 to 100. A higher score represents a higher level of functioning or a higher level of symptoms, depending on the items.

8 subsections. No total score.

1. Identity. Score between 0 and 14. Higher score indicates a higher number of symptoms.
2. Timeline. Higher score = strongly held negative beliefs about the chronicity of the illness.
3. Consequences. Higher score = strongly held beliefs about the negative consequences of the illness.
4. Personal control. Higher score = positive beliefs about the controllability of the illness.
5. Treatment control. Higher score = positive beliefs about the effectiveness of treatment to improve the illness and/or to control the symptoms.
6. Coherence. Higher score = positive beliefs about the personal understanding of the illness.
7. Cyclical timeline. Score between 4 and 20. Higher score = strong negative beliefs about the cyclical nature of the illness.
8. Emotional representation. A higher score = more negative emotions related to the illness.

Score between 5 and 25 for subscale 2, 5, 6. Score between 6 and 30 for subscale 3, 4, 8.

27-item questionnaire rated on a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). Total score is obtained by adding up the responses of the items. Total score may vary from 27 to 135. The higher the score, the higher the severity level of intolerance to uncertainty.

25-item questionnaire developed to assess the beliefs related to the worries about the illness. Items are divided in 5 subscales, subscale scores varying between 5 and 25 and each subscale assessing why a person might worry. Higher scores indicate reasons why a person worries.

25-item questionnaire rated on a 5-point Likert scale ranging from 1 (not at all corresponding) to 5 (entirely corresponding). Total score varies between 25 and 125. The higher the score, the higher the level of cognitive avoidance.

10-item questionnaire rated with a Likert-like scale ranging from 0 (none of the time) to 4 (all of the time). Total scores vary from 0 to 40, a higher score indicating a higher level of worry behaviors.

3-item subscale with a Likert-like subscale ranging from 0 (not at all or rarely) to 3 (most of the time). Total score varies from 0 to 9, a higher score indicating a higher need for reassurance seeking behaviors.

10-item questionnaire assessing the extent to which patients report feeling reassured by their attending physician. Questions are rated from not at all to most of the time. Scores vary from 10 to 40. The higher the score, the lower the feeling of reassurance.

3-item subscale rated with a Likert-like scale ranging from 0 (not at all) to 4 (very much). Total score varies between 0 and 12. A higher score indicates a greater importance given to staying in control.

This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.

This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.

Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?