RecruitingNot ApplicableNCT07379138

Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improvement of Quality of Life in Stage III-IV Melanoma Patients

Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)


Sponsor

Mayo Clinic

Enrollment

350 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the quality of life — including mental health and emotional wellbeing — of patients newly diagnosed with Stage III or IV melanoma (an advanced skin cancer), and tests whether cognitive behavioral therapy (CBT) can help reduce distress and improve mental health outcomes. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with Stage III or IV melanoma within the past 2 months - You can read English well enough to complete questionnaires and informed consent **You may NOT be eligible if...** - You do not meet the above inclusion criteria Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

OTHERBest Practice

Receive SOC

BEHAVIORALCognitive Behavior Therapy

Attend CBT-C sessions

OTHERElectronic Health Record Review

Ancillary studies

OTHERQuestionnaire Administration

Complete QOL-MH questionnaires


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07379138


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