Improving quality of life with cognitive behavioral therapy for people treated for stage III–IV melanoma
Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)
NA · Mayo Clinic · NCT07379138
This study will test whether cognitive behavioral therapy for cancer distress (CBT-C) helps adults treated for stage III–IV melanoma feel and function better during the first two years after treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07379138 on ClinicalTrials.gov |
What this trial studies
Adults newly diagnosed with stage III or IV melanoma (within two months) will be followed for two years to measure quality of life with attention to mental health. Participants will receive cognitive behavioral therapy for cancer distress (CBT-C) or best-practice care and will complete regular questionnaires about sleep, concentration, mood, social function, and daily activities. Electronic health records will be reviewed alongside patient-reported outcomes to track symptoms and health care use over time. The study aims to determine whether adding CBT-C improves overall quality of life compared with standard approaches.
Who should consider this trial
Good fit: Adults aged 18 or older with a new (within two months) diagnosis of stage III or IV melanoma who can read English and complete surveys are the intended participants.
Not a fit: People who are under 18, do not have stage III–IV melanoma within two months of diagnosis, or cannot complete English-language surveys are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, CBT-C could reduce cancer-related distress and improve sleep, concentration, social functioning, and overall quality of life for people treated for advanced melanoma.
How similar studies have performed: Cognitive behavioral therapies have improved distress and quality of life in other cancer populations, but CBT-C specifically for stage III–IV melanoma is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18-years * Stage III-IV melanoma and =\< 2 month duration of this diagnosis * Able to read English sufficient to complete survey, informed consent Exclusion Criteria: * Does not meet inclusion criteria
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Shawna L. Ehlers, PhD, LP — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Melanoma