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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CHU de Québec-Université Laval
RECRUITING
Québec
Contact Information
Primary
Emma Coughlan
emma.coughlan@crchudequebec.ulaval.ca
418-525-4444
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 250
Treatments
Experimental: Immediate intervention
This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.
Active_comparator: Waiting list group
This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.
Related Therapeutic Areas
Sponsors
Leads: CHU de Quebec-Universite Laval

This content was sourced from clinicaltrials.gov