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

Study acronym: CBT-FCRBRCA1/2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Enrollment target: 50 to 250
    • Start date: Jun 2025 to Feb 2026
    • Study completion date: Dec 2027 to Dec 2028
    • Eligibility criteria expanded, about 26 words
    • Study description shortened, about 47 words
  2. Primary endpoint revised
    • Secondary endpoints revised (12)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06817694
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Breast Cancer Susceptibility Gene (BRCA1) Mutation, BRCA2 Mutation, Fear of Cancer Recurrence
Related terms Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov