RecruitingNot ApplicableNCT06817694

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

Sponsor

CHU de Quebec-Universite Laval

Enrollment

250 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

BRCA2 Mutation Fear of Cancer Recurrence Breast Cancer Susceptibility Gene (BRCA1) Mutation

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial tests whether a cognitive-behavioral therapy (CBT) program — adapted specifically for women who carry a BRCA1/2 gene mutation — can reduce fear of cancer recurrence (FCR), which is the persistent worry that cancer will come back or spread. Women with this mutation face a significantly higher lifetime risk of breast and ovarian cancer, and FCR is known to be a major source of distress in this group that prophylactic surgery alone does not resolve. Women aged 18 and older who have completed primary treatment for breast or ovarian cancer, carry a confirmed BRCA1/2 mutation, and have a clinical level of FCR (as measured by a validated questionnaire score of 13 or higher) are eligible; the program is offered in French by videoconference. Participation involves 7 weekly online group therapy sessions of 90 minutes each, plus questionnaires at the start, end, 3 months, and 6 months post-treatment. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive-behavioral group therapy

The intervention consists of a 4-week cognitive-behavioral group therapy. Each session is given online and will last 90-minutes. The intervention has been adapted to the population of women with a cancer and a BRCA1/2 mutation from a behavioral-cognitive therapy for fear of cancer recurrence that already exists and has already been proven effective.