250 Participants NeededMy employer runs this trial

Cognitive Behavioral Therapy for Cancer Anxiety

(CBT-FCRBRCA1/2 Trial)

EC
Overseen ByEmma Coughlan
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: CHU de Quebec-Universite Laval
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cognitive-behavioral therapy (CBT) can assist women with a BRCA1/2 genetic mutation who worry about cancer recurrence. The researchers aim to determine if this therapy can reduce their fear of cancer returning and improve overall well-being, such as decreasing anxiety and enhancing sleep. Participants will either begin therapy immediately or after a short delay. Women who have completed treatment for breast or ovarian cancer and can speak French may qualify. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance support for women with similar concerns.

What prior data suggests that this cognitive-behavioral therapy protocol is safe for cancer survivors?

Research has shown that cognitive-behavioral therapy (CBT) is generally safe and well-tolerated by patients. Studies have found that CBT can significantly enhance mental health and quality of life for cancer patients, with moderate improvements observed in various trials. For example, one study found that CBT reduced anxiety and depression in cancer patients within a few weeks. Another study showed that CBT improved the mental well-being of glioma patients undergoing chemotherapy.

Additionally, group CBT has effectively reduced mental distress, especially among women with breast cancer. Most participants in these studies reported significant improvements, with benefits lasting up to 26 weeks. These findings suggest that CBT is a safe option for managing anxiety and related issues in cancer survivors.12345

Why are researchers excited about this trial?

Cognitive-behavioral group therapy is unique because it specifically targets the anxiety experienced by cancer patients through structured group sessions. Unlike traditional treatments such as medication or individual therapy, this approach leverages the power of group dynamics, providing peer support and shared experiences which can enhance coping strategies. Researchers are excited about this treatment because it offers a non-pharmacological option that could reduce anxiety symptoms without the potential side effects of medication, and it empowers patients by equipping them with practical skills to manage their anxiety more effectively.

What evidence suggests that this cognitive-behavioral group therapy is effective for reducing fear of cancer recurrence?

Research shows that cognitive-behavioral therapy (CBT) helps reduce anxiety and depression in cancer patients. Studies have found that CBT improves mental health and quality of life for these individuals. One study found that CBT greatly reduced psychological symptoms in cancer patients. Another study showed that people who participated in group CBT experienced less anxiety and depression during follow-up check-ins. In this trial, participants will either receive immediate intervention with CBT or be placed on a waiting list before starting the same intervention. Overall, CBT provides important emotional and psychological benefits for cancer survivors, making it a promising option for those facing cancer-related anxiety.12678

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a BRCA1 or BRCA2 gene mutation.
I finished main treatment for breast or ovarian cancer 3 months to 10 years ago.
I am very worried about my cancer coming back, scoring 13 or more on a fear scale.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 7 weekly group CBT sessions for fear of cancer recurrence

7 weeks
7 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Questionnaires at 3 and 6 months post-intervention

Waitlist Control

Participants in the waitlist condition wait for 7 weeks before starting the intervention

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive-behavioral group therapy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Immediate interventionExperimental Treatment1 Intervention
Group II: Waiting list groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials
177
Recruited
110,000+

Citations

The efficacy of cognitive behavioral therapy for mental health ...

CBT statistically improves the MH and QoL psychosocial parameters in cancer patients with greater efficacy in younger patients.

2559P Effectiveness of cognitive behavioral therapy in ...

Conclusions. CBT significantly reduced psychological symptoms in patients with cancer. These findings support integrating validated psychological screening ...

Cognitive behavioral therapy for anxiety and depression in ...

This study aimed to investigate the effects of cognitive behavioral therapy (CBT) on anxiety and depression in cancer survivors.

Effects of cognitive behavioral therapy on anxiety and ...

Cognitive behavioral therapy lasting for 2–8 weeks is effective for anxiety and depressive symptoms in advanced cancer patients to a moderate degree.

CBT Benefits Cancer Patients' Mental Health and ...

Cognitive behavioral therapy (CBT) offers significant benefits for patients with cancer by addressing the emotional and psychological challenges that often ...

The impact of cognitive behavioral therapy on disease ... - PMC

The study revealed that the group that received CBT showed significant improvements in the psychological well-being of glioma patients undergoing chemotherapy.

Effects of cognitive behavioral therapy on resilience among ...

The results of this study indicate CBT can improve resilience among cancer patients. These findings underscore the importance of considering ...

A Randomized Clinical Trial - Jefferson Digital Commons

PURPOSE Anxiety is prevalent, disruptive, and undertreated among survivors of cancer. Cognitive behavioral therapy (CBT) is the first-line ...