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

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: Melanoma
• Intervention / Treatment: Other: Best Practice; Other: Electronic Health Record Review; Other: Questionnaire Administration; Behavioral: Cognitive Behavior Therapy

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Deanna Hofschulte; Phone Number: 507-255-2972
      • Principal Investigator: Shawna L. Ehlers, PhD, LP

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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)	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)	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)	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	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	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	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	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	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	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	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

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

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): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Cognitive Behavioral Therapy; Practice Guidelines as Topic
• Other Study ID Numbers: 25-007199 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2026-00039 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 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