RecruitingNAINTERVENTIONAL

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

This study is testing a type of talking therapy called Cognitive Behavioural Therapy (CBT) for women who have inherited a faulty BRCA1 or BRCA2 gene. These gene changes increase the risk of certain cancers, which can lead to a strong fear of cancer returning, even if they've already had treatment. The therapy is given in online groups over eleven weeks. Researchers want to find out if this adapted CBT helps reduce worries about cancer coming back and improves other difficult feelings like anxiety, depression, and sleep problems. They also want to see if the positive effects last over time. Participants will fill out questionnaires before, during, and after the therapy to track their progress.

At a glance

Status

Recruiting

Phase

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

250

Start

01 Feb 2026

Estimated completion

01 Dec 2028

Breast Cancer Susceptibility Gene (BRCA1) Mutation BRCA2 Mutation Fear of Cancer Recurrence

What is this study about?

Imagine you've been told you have a gene change, like BRCA1 or BRCA2, that puts you at a higher risk of cancer, or you've already had cancer because of it. It's very common to worry that the cancer might come back. This worry can be light for some, but for others, it can be very strong and upsetting, affecting daily life, mood, and sleep. This strong worry is what doctors call 'fear of cancer recurrence' (FCR).

This study is looking at whether a special type of talking therapy, called Cognitive Behavioural Therapy (CBT), can help women with the BRCA1/2 gene fault manage this fear. CBT is a common therapy that helps people understand and change unhelpful patterns of thinking and behaviour. The researchers have taken an existing CBT program that has worked for other cancer survivors and adjusted it specifically for women with the BRCA1/2 gene change.

The main goal is to see if this adapted CBT can significantly reduce the fear of cancer coming back. They also want to check if it helps with other things often linked to worry, such as feeling down, anxious, having trouble sleeping, or feeling very tired. The study will also explore whether the benefits of the therapy last for several months after it finishes and what parts of the therapy are most helpful.

Key takeaways

This study evaluates online CBT for women with BRCA1/2 gene changes.
It aims to reduce worries about cancer returning (fear of recurrence).
It may also improve anxiety, depression, sleep, and overall well-being.
Participation involves 11 weekly online group sessions and questionnaires.
You need to have completed primary cancer treatment for breast or ovarian cancer and have a BRCA1/2 gene change.
The therapy and assessments are in French.

Who may be eligible?

To join this study, you need to be a woman aged 18 or over who has finished your main treatment for breast or ovarian cancer (like surgery, chemotherapy, and radiotherapy). Importantly, you must know that you carry a specific BRCA1 or BRCA2 gene change that increases your cancer risk.

You also need to be experiencing a significant level of worry about your cancer coming back, which will be measured using a specific questionnaire. You should be able to read, understand, and speak French comfortably, as the therapy sessions and materials will be in French.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to other parts of your body, or if you have a less clear BRCA1/2 gene change (called a 'VUS'). If you have a severe memory or thinking problem, or a serious mental health condition like a psychotic disorder or severe addiction, you might not be eligible. Also, if you've already had the original FCR group therapy at CHU de Québec, you won't be able to join this study. If you take medication for your mood, you can still participate, as long as the dose has been steady for at least a month.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman aged 18 or older.
I have finished my main treatment for breast or ovarian cancer.
I know I have a BRCA1 or BRCA2 gene change.
I am experiencing significant worries about cancer coming back.
I can comfortably read, understand, and speak French.
I do not have cancer that has spread to distant parts of my body.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups. One group will start the special online CBT therapy straight away, and the other group will be on a 'waitlist' and start their therapy once the first group has finished theirs. Each therapy session will be online, with a group, once a week for eleven weeks.

Throughout the study, you'll be asked to fill out several questionnaires. You'll complete them before the therapy starts, again right after it finishes, and then two more times at three months and six months after the therapy ends. This helps the researchers understand how you're feeling over time and if the therapy has helped you.

Potential risks and benefits

Taking part in this study may offer several potential benefits. The main aim is to help you reduce your worries about cancer returning, and potentially improve your mood, sleep, and overall quality of life. As with any therapy, some people might find talking about their fears challenging or upsetting at times, but the therapists are trained to support you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Québec-Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is a BRCA1/2 gene change?

BRCA1 and BRCA2 are genes that normally help protect you from cancer. If you have an inherited fault in one of these genes, it means you have a higher risk of developing certain cancers, like breast or ovarian cancer.

What is Cognitive Behavioural Therapy (CBT)?

CBT is a common type of talking therapy that helps people identify and change unhelpful thinking patterns and behaviours that might be causing them distress. It's often used for anxiety, depression, and other emotional difficulties.

Will I get this therapy even if I'm on the waitlist?

Yes, if you're in the waitlist group, you will receive the same CBT therapy, but it will start after the group that began straight away has finished their sessions.

How long will I be involved in the study?

The online therapy sessions last for eleven weeks. You'll also complete questionnaires before, during, and up to six months after the therapy, so the total involvement will be several months.

Do I need to pay to join this study?

No, participating in a clinical trial should not cost you money. The therapy sessions and any study-related assessments are provided as part of the research.

How to find out more

Emma Coughlan

emma.coughlan@crchudequebec.ulaval.ca 418-525-4444 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.