Cognitive Behavioral Therapy for Fear of Cancer Recurrence
Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
Recruiting
N/AInterventional Study
Breast Cancer Susceptibility Gene (BRCA1) MutationBRCA2 MutationFear of Cancer Recurrence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
CHU de Quebec-Universite Laval · Other
Who this trial is looking for
This trial is looking for women who have a BRCA1/2 gene mutation and fear of their cancer coming back. Participants will take part in weekly online therapy sessions for eleven weeks and fill out questionnaires before and after the program.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed treatment for breast or ovarian cancer
I have a BRCA1/2 pathogenic mutation
I have a high level of fear of cancer recurrence
I am at least 18 years old
I can read and understand French
You may not be able to join if
I have distant metastatic cancer
I have a BRCA1/2 'VUS' mutation
I have a cognitive disorder
I have a severe psychological disorder
I have participated in the original FCR group therapy
I am taking psychotropic medication and my dosage has not been stable for at least one month
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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 Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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