350 Participants Needed

Cognitive Behavioral Therapy for Melanoma

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
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 aims to determine if cognitive behavioral therapy for cancer distress (CBT-C) can improve the quality of life for individuals with stage III-IV melanoma after treatment. It examines how patients feel and manage daily life, focusing on stress, sleep problems, and social life changes. Participants will either attend weekly CBT-C sessions or receive standard care for six weeks. Eligible participants should have been diagnosed with stage III-IV melanoma within the last two months and be able to read English. As an unphased trial, this study offers a unique opportunity to explore new methods for enhancing well-being and managing cancer-related challenges.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cognitive behavioral therapy is safe for melanoma patients?

Research shows that cognitive behavioral therapy (CBT) is safe and well-tolerated for people experiencing cancer-related stress. Past studies have found that CBT significantly reduces distress and improves the quality of life for patients with melanoma. One study found that CBT lowered anxiety and depression, with benefits lasting at least six months. Another study showed that CBT could boost resilience, helping patients handle stress and emotional challenges better.

These studies found no evidence of serious side effects from CBT, suggesting it is a safe option for cancer patients seeking to improve their mental well-being. For those considering joining a trial that includes CBT, research suggests it could be a helpful and safe choice for enhancing quality of life.12345

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for melanoma patients because it offers a unique way to address mental health challenges alongside physical treatment. Unlike traditional care that focuses primarily on the physical aspects of melanoma, CBT targets the emotional and psychological well-being of patients, helping them cope with the stress and anxiety that can accompany a cancer diagnosis. This approach is especially noteworthy because it could enhance patients' overall quality of life, potentially leading to better treatment outcomes. By integrating mental health support with cancer care, CBT aims to provide a more holistic treatment experience for patients.

What evidence suggests that cognitive behavioral therapy could be effective for improving quality of life in melanoma patients?

Research has shown that cognitive behavioral therapy (CBT) can greatly help cancer patients manage stress and improve their quality of life. In this trial, some participants will attend CBT sessions once a week for six weeks. One study found that CBT reduced stress and improved the well-being of melanoma patients experiencing moderate to high levels of distress. Another study found that CBT significantly improved depression in cancer survivors, even months after the therapy ended. Evidence suggests that CBT is one of the most effective psychological treatments for enhancing overall quality of life and reducing fatigue from cancer treatments. These findings indicate that CBT could greatly benefit people facing the stress and challenges of melanoma.12467

Who Is on the Research Team?

SL

Shawna L. Ehlers, PhD, LP

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage III-IV melanoma diagnosed within the last two months. Participants must be able to read English well enough to understand surveys and consent forms.

Inclusion Criteria

My melanoma is at stage III-IV and was diagnosed within the last 2 months.
I can read and understand English well enough to fill out a survey and consent form.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend CBT-C sessions once a week for 6 weeks or receive SOC for 6 weeks

6 weeks
6 visits (in-person)

Quality of Life Assessment

Participants complete QOL-MH questionnaires at baseline and 3, 6, 9, 12, 18, and 24 months post-stage III-IV diagnosis

24 months
7 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavior Therapy

Trial Overview

The study looks at how quality of life, including mental health, is affected after melanoma treatment. It tests if cognitive behavioral therapy specifically designed for cancer-related stress can improve life for those recently treated for advanced melanoma.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Aim 2 arm I (CBT-C)Experimental Treatment3 Interventions
Group II: Aim 1 (QOL-MH)Experimental Treatment2 Interventions
Group III: Aim 2 arm II (SOC)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12910531/

Cognitive-behavioral intervention for distress in patients with ...

The four-session CBI significantly reduced distress and improved HRQOL for a period of 2 months in patients with melanoma who had medium-to-high distress.

Studying Quality of Life Inclusive of Mental Health and ...

This clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive ...

The efficacy of cognitive behavioral therapy for cancer - PMC

Cognitive behavioral therapy (CBT) is one of the most recognized psychological interventions to improve the overall quality of life of cancer survivors.

Cognitive behavioral therapy for anxiety and depression in ...

The pooled results suggested that CBT significantly improved the depression scores of the cancer survivors after the intervention and at the 6- ...

The efficacy of cognitive behavioral therapy for cancer

Evidence suggests that CBT is the most effective psychological intervention to improve tiredness caused by cancer therapy and can make the ...

Cognitive‐behavioral intervention for distress in patients with ...

The current study was designed to determine the effect of a cognitive-behavioral intervention on distress and health-related quality of life ( ...

Effects of cognitive behavioral therapy on resilience among ...

This study provided moderately strong evidence that CBT is a valuable tool for enhancing resilience among cancer patients.