Recruiting

CBT for BRCA1/2

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT06817694

Conditions

Breast Cancer Susceptibility Gene (BRCA1) Mutation

BRCA2 Mutation

Fear of Cancer Recurrence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-behavioral group therapy

Study Details

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.

Conditions

Breast Cancer Susceptibility Gene (BRCA1) Mutation

BRCA2 Mutation

Fear of Cancer Recurrence

Study ID

NCT06817694

Start date

Feb, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate intervention

This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.

active comparator: Waiting list group

This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.

Interventions

Cognitive-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.

Primary outcome measure

  • Fear of cancer recurrence inventory (FCRI) [ Time Frame: At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention ]

Central Contacts and Locations

Central contacts

Emma Coughlan

418-525-4444emma.coughlan@crchudequebec.ulaval.ca

Locations

CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • BRCA1 Mutation
  • BRCA 2 Mutation
  • Fear of cancer recurrence
  • Cognitive-Behavioral Therapy
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-03-31.