NCT06817694 Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
| NCT ID | NCT06817694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Breast Cancer Susceptibility Gene (BRCA1) Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06817694 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Susceptibility Gene (BRCA1) Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817694 currently recruiting?
Yes, NCT06817694 is actively recruiting participants. Contact the research team at emma.coughlan@crchudequebec.ulaval.ca for enrollment information.
Where is the NCT06817694 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT06817694 clinical trial?
NCT06817694 is sponsored by CHU de Quebec-Universite Laval. The trial plans to enroll 250 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.