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

NCT06817694 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06817694 on ClinicalTrials.gov