Clinical trial for Breast Cancer Susceptibility Gene (BRCA1) Mutation
Official title Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
ClinicalTrials.gov ID: NCT06817694
What this study is testing
- What it's testing
- The study tests if a specially adapted group CBT can lower fear of cancer recurrence and improve mood, sleep, and quality of life in women with BRCA1/2 mutations.
- Who it's for
- Women who carry a BRCA1 or BRCA2 gene mutation and are concerned about cancer coming back.
- What's involved
- Participants join an online group CBT once a week for 11 weeks and fill out questionnaires before, after, and at follow‑up times.
- Time commitment
- The program lasts 11 weeks, with weekly online sessions and several questionnaire visits up to 6 months after the start.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 4) Be at least 18 years of age.
- 5) Be able to read, understand and express herself in French.
You likely can't join if
- 1) Have distant metastases (in the case of ovarian cancer, only stages IV and IIIC will be excluded).
- 2) Be known to carry a BRCA1/2 "VUS" mutation.
- 3) Have a known cognitive disorder.
- 4) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).
- 5) Have already taken part in the original FCR group psychotherapy at the CHU de Québec.
- 6) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.