Recruiting

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

ClinicalTrials.gov IDNCT06817694

PhaseNA

Enrollment250

SponsorCHU de Quebec-Universite Laval

Age18 Years

SexFEMALE

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Conditions studied

Breast Cancer Susceptibility Gene (BRCA1) Mutation, BRCA2 Mutation, Fear of Cancer Recurrence

About this study

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.

Interventions

Behavioral: 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 outcomes

Fear of cancer recurrence inventory (FCRI) (At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention)

Eligibility information

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 locations

CHU de Québec-Université Laval, Québec, Quebec Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.