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 clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive behavioral therapy for cancer distress (CBT-C) works to improve quality of life in patients with stage III-IV melanoma. The melanoma survivorship population is rapidly growing, given the increasing survival rates due to treatment advancements. An urgent need to better define and optimize comprehensive quality of life inclusive of mental health (QOL-MH) has been identified. Cognitive behavioral therapy is a type of psychotherapy that helps patients change their behavior by changing the way they think and feel about certain things. CBT-C is a new type of care that helps patients cope with cancer-related stress, which can include problems like trouble sleeping, trouble focusing, or changes in social life and daily activities. Gathering information on how melanoma patients feel and live during the first two years after treatment may help promote improved care and continued scientific advancements in the understanding of melanoma specific QOL-MH and survivorship as a whole, and may also help determine whether CBT-C improves qualify of life in patients with stage III-IV melanoma.

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+