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
NCT07379138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2026-01-30
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.
Conditions
Interventions
- OTHER
-
Best Practice
Receive SOC
- BEHAVIORAL
-
Cognitive Behavior Therapy
Attend CBT-C sessions
- OTHER
-
Electronic Health Record Review
Ancillary studies
- OTHER
-
Questionnaire Administration
Complete QOL-MH questionnaires
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Shawna L. Ehlers, PhD, LP · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-10
- Primary Completion
- 2031-12-31
- Completion
- 2031-12-31
Countries
- United States
Study Locations
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