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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07379138
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive SOC
  • Cognitive Behavior Therapy — BEHAVIORAL
    Attend CBT-C sessions
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Complete QOL-MH questionnaires

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Aim 1 (QOL-MH)
    Patients complete QOL-MH questionnaires at baseline and 3, 6, 9, 12, 18, and 24-months post-stage III-IV diagnosis. Patients living in Minnesota, Iowa, or Wisconsin may also optionally participate in aim 2.
  • Experimental: Aim 2 arm I (CBT-C)
    Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity.
  • Active Comparator: Aim 2 arm II (SOC)
    Patients receive SOC for 6 weeks in the absence of unacceptable toxicity.

Primary Outcome Measure

Change in FACT-M total score (Aim 1) [ Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Deanna Hofschulte
507-255-2972
Shawna L. Ehlers, PhD, LP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Mayo Clinic in Rochester· Rochester, MN

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