Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06817694

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

Led by CHU de Quebec-Universite Laval · Updated on 2026-03-31

250

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Have completed primary treatment for breast or ovarian cancer (surgery, chemotherapy, and radiotherapy)
  • Known carrier of a BRCA1 or BRCA2 pathogenic mutation
  • Clinical level of fear of cancer recurrence with a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale
  • At least 18 years of age
  • Able to read, understand, and express herself in French
Not Eligible

You will not qualify if you...

  • Have distant metastases (for ovarian cancer, stages IV and IIIC are excluded)
  • Carry a BRCA1/2 "VUS" mutation
  • Have a known cognitive disorder
  • Have a severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence)
  • Have previously participated in the original FCR group psychotherapy at CHU de Québec
  • Women taking psychotropic medication must have had a stable dosage for at least one month to be eligible

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Québec-Université Laval

Québec, Quebec, Canada

Actively Recruiting

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Research Team

E

Emma Coughlan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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