Adapted group cognitive-behavioral therapy for fear of cancer returning in women with BRCA1 or BRCA2 mutations

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

This project tests an adapted group cognitive-behavioral therapy to reduce fear of cancer returning in women who carry BRCA1 or BRCA2 mutations and have finished primary treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: CHU de Quebec-Universite Laval (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Québec, Quebec)
• Trial ID: NCT06817694 on ClinicalTrials.gov

What this trial studies

Participants with a pathogenic BRCA1/2 mutation and clinical-level fear of cancer recurrence will be randomized to receive an adapted group CBT intervention immediately or to a waitlist control, with sessions delivered at CHU de Québec–Université Laval. Outcomes measured include severity of fear of cancer recurrence as the primary endpoint and secondary measures such as depression, anxiety, insomnia, fatigue, quality of life, and participant satisfaction, assessed at baseline, post-intervention, and follow-up visits. The protocol modifies an existing FCR group CBT to address concerns specific to BRCA carriers and will analyze mediating psychological variables that may explain treatment effects. The study compares immediate versus delayed treatment to test both short-term effects and durability over time.

Who should consider this trial

Good fit: Women aged 18 or older who speak French, carry a pathogenic BRCA1 or BRCA2 mutation, have completed primary treatment for breast or ovarian cancer, and score 13 or higher on the FCRI severity subscale are the ideal candidates.

Not a fit: Patients with distant metastases (or excluded advanced ovarian stages), a BRCA variant of uncertain significance (VUS), known cognitive impairment, severe psychiatric disorders, prior participation in the original on-site FCR group, or inability to participate in French are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the adapted group CBT could reduce persistent fear of cancer recurrence and improve mental health and quality of life for women with BRCA1/2 mutations.

How similar studies have performed: Prior group CBT programs for fear of cancer recurrence have shown promising results in reducing FCR and related symptoms, though this BRCA-specific adaptation is a more novel application.

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.

Where this trial is running

Québec, Quebec

• CHU de Québec-Université Laval — Québec, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Emma Coughlan

Conditions Breast Cancer Susceptibility Gene Mutation; BRCA2 Mutation; Fear of Cancer Recurrence; BRCA1 Mutation; BRCA 2 Mutation; Fear of cancer recurrence; Cognitive-Behavioral Therapy; Cancer