Recruiting

CBT-C

Sponsor:

Mayo Clinic

Code:

NCT07379138

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Cognitive Behavior Therapy

Electronic Health Record Review

Questionnaire Administration

Study Details

Brief 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

Melanoma

Study ID

NCT07379138

Start date

Dec 10, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Best Practice

Receive SOC

Cognitive Behavior Therapy

Attend CBT-C sessions

Electronic Health Record Review

Ancillary studies

Questionnaire Administration

Complete QOL-MH questionnaires

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 ]
  • Change in FACT-ICM total score (Aim 1) [ Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months ]
  • Change in Impact of Events Scale-Revised (IES-R) score (Aim 1) [ Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months ]
  • Change in IES-R score (Aim 2) [ Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Deanna Hofschulte

507-255-2972

Principal Investigator:

Shawna L. Ehlers, PhD, LP

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-22.