Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06817694

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

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

250

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate an adapted cognitive-behavioral group therapy (CBT) designed specifically for women who carry the BRCA1 or BRCA2 genetic mutations and have a history of breast or ovarian cancer. These women often experience high and persistent fear of cancer recurrence (FCR), which can cause anxiety, depression, and reduced quality of life. The study will compare the effects of this tailored CBT program against a waitlist control to see if it reduces FCR and improves related symptoms over time. Participants will be randomly assigned to either an immediate intervention group or a waitlist group. The immediate group will participate in seven weekly 90-minute group CBT sessions conducted online via videoconference by trained psychologists. The waitlist group will complete questionnaires for seven weeks before receiving the same CBT intervention. The therapy is adapted to address the unique needs of BRCA1/2 mutation carriers, including concerns about cancer recurrence and life decisions impacted by their genetic risk. During the study, women will complete questionnaires before the intervention, immediately after, and at three and six months post-intervention. These questionnaires assess fear of cancer recurrence, anxiety, depression, insomnia, fatigue, quality of life, and other psychological factors. Researchers will monitor satisfaction with the therapy and changes in these measures over time. The total participation includes the therapy period and follow-up assessments, with ongoing evaluation of how the adapted CBT affects fear and related symptoms.

CONDITIONS

Brief 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, radiotherapy)
  • Known carrier of a BRCA1 or BRCA2 pathogenic mutation
  • Have a clinical level of fear of cancer recurrence with a Fear of Cancer Recurrence Inventory severity score of 13 or more
  • At least 18 years old
  • 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 excluded)
  • Carry a BRCA1/2 "VUS" mutation
  • Have a known cognitive disorder
  • Have a severe psychological disorder such as psychotic disorder, bipolar disorder, or substance abuse
  • Previously participated in the original fear of cancer recurrence group psychotherapy at CHU de Québec
  • Taking psychotropic medication only if dosage has not been stable for at least one month

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (telephone interview)

Outpatient Treatment

Duration - 7 weeks

Participants receive 7 weekly group cognitive-behavioral therapy sessions for fear of cancer recurrence. Each session lasts 90 minutes and is conducted online via videoconference.

7 weekly visits (online group sessions)

Follow-up

Duration - 6 months post intervention

Participants complete follow-up assessments to measure fear of cancer recurrence and other psychological outcomes at 3 and 6 months after the intervention ends.

3 visits (at 4 weeks, 3 months, and 6 months post intervention)

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

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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Published Research Related To This Trial

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence.

Phyllis N Butow, Jane Turner, Jemma Gilchrist...

https://pubmed.ncbi.nlm.nih.gov/29095681