Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene (NCT06817694) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
Canada250 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Have completed primary treatment for breast or ovarian cancer (i.e., surgery, chemotherapy, and radiotherapy).
* 2\) Be known to carry a BRCA1/2 pathogenic mutation.
* 3\) Have a clinical level of fear of cancer recurrence as defined by a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale.
* 4\) Be at least 18 years of age.
* 5\) Be able to read, understand and express herself in French.
Exclusion Criteria:
* 1\) Have distant metastases (in the case of ovarian cancer, only stages IV and IIIC will be excluded).
* 2\) Be known to carry a BRCA1/2 "VUS" mutation.
* 3\) Have a known cognitive disorder.
* 4\) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).
* 5\) Have already taken part in the original FCR group psychotherapy at the CHU de Québec.
* 6\) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fear of cancer recurrence inventory (FCRI)
Timeframe: At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention