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

June 18, 2026 updated by: Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
          • Deanna Hofschulte
          • Phone Number: 507-255-2972
        • Principal Investigator:
          • Shawna L. Ehlers, PhD, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Electronic Health Record Review
Ancillary studies
Other: Questionnaire Administration
Complete QOL-MH questionnaires
Experimental: Aim 2 arm I (CBT-C)
Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity.
Other: Electronic Health Record Review
Ancillary studies
Other: Questionnaire Administration
Complete QOL-MH questionnaires
Behavioral: Cognitive Behavior Therapy
Attend CBT-C sessions
Other Names:
  • CT
  • CBT
  • cognitive therapy
Active Comparator: Aim 2 arm II (SOC)
Patients receive SOC for 6 weeks in the absence of unacceptable toxicity.
Other: Best Practice
Receive SOC
Other Names:
  • standard of care
  • standard therapy
Other: Electronic Health Record Review
Ancillary studies
Other: Questionnaire Administration
Complete QOL-MH questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FACT-M total score (Aim 1)
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Functional Assessment of Cancer Therapy - Melanoma (FACT-M) is a 52-item questionnaire used to measures quality of life (QoL) in melanoma cancer patients. Responses to each item are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-108 with higher scores indicating better quality of life. For this study, 8 items have been omitted, so the number of items is 44, with total scores ranging from 0-176. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
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
The Functional Assessment of Cancer Therapy - Immune Checkpoint Modulator (FACT-ICM) is a 25-item subscale that measures symptom burden and health-related quality of life (HRQoL) over the past 7 days in patients receiving immune checkpoint inhibitors. Responses to each question are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores range from 0-100 with higher scores indicating greater symptom burden and poorer quality of life. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
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
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess subjective distress related to stressful life events. The IES-R consists of 22 items for which participants rate how distressing each difficulty has been during the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress. Descriptive statistics will be used to tabulate and graph the observed total scores and the change from baseline total scores over time.
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
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure designed to assess distress related to stressful life events. The IES-R consists of 22 items which participants rate distress over the past 7 days with regard to their cancer diagnosis. Responses are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Scores range from 0-88 with higher scores indicating greater distress.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PHQ-8 score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Patient Health Questionnaire-8 (PHQ-8) is a brief, self-report tool used to screen for and measure the severity of depression by asking about 8 depressive symptoms over the past two weeks, scoring from 0 (not at all) to 3 (nearly every day) for each, with total scores indicating severity (e.g., 0-4 minimal, 10-14 moderate) and a score of 10 or more often suggesting major depression.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in GAD-7 Anxiety score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The General Anxiety Disorder 7-item (GAD-7) scale is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. If patients indicate any problems they are asked to indicate how difficult the problems have made daily life: not difficult at all, somewhat difficult, very difficult, or extremely difficult.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PSQI score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Pittsburgh Sleep Quality Index (PSQI)measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Fatigue score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Patient-Reported Outcomes Measurement Information System (PROMIS): Fatigue questionnaire, a subscale of the PROMIS-29, measures fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). A higher score indicates greater experience of fatigue.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in PROMIS: Pain Interference score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The PROMIS: Pain Interference questionnaire, a subscale of the PROMIS-29, is used to assess pain interference in daily life over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). A higher score indicates greater levels of pain interference.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in COST-FACIT score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COSTFACIT) measures financial toxicity among cancer patients. This measure reflects five themes of financial toxicity which include: financial, resource, affect, coping, and effect on family. It consists of 12 questions, each answered on a scale of 0 (not at all) to 5 (very much), with higher scores indicating greater financial toxicity.
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Change in MEPS score
Time Frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
The Medical Expenditures Survey (MEPS) measures the financial impact of cancer, its treatment, or the lasting effects of that treatment. It consists of 5 multiple choice questions, including free text/ / fill-in options where appropriate. Results are reported descriptively. .
Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Shawna L. Ehlers, PhD, LP, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-007199 (Mayo Clinic Institutional Review Board)
  • HT9425-25-1-0802 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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