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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Québec-Université Laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Emma Coughlan
• Email: emma.coughlan@crchudequebec.ulaval.ca
• Phone: 418-525-4444

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.