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

NCT07379138 | Recruiting

• 3 other identifiers: 25-007199NCI-2026-00039HT9425-25-1-0802
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Change in PHQ-8 score

  Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

• Change in GAD-7 Anxiety score

  Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

• Change in PSQI score

  Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

• Change in PROMIS: Fatigue score

  Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

• Change in PROMIS: Pain Interference score

  Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months

Study Arms (3)

Aim 1 (QOL-MH)

EXPERIMENTAL

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; Other: Questionnaire Administration

Aim 2 arm I (CBT-C)

EXPERIMENTAL

Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity.

Behavioral: Cognitive Behavior Therapy; Other: Electronic Health Record Review; Other: Questionnaire Administration

Aim 2 arm II (SOC)

ACTIVE COMPARATOR

Patients receive SOC for 6 weeks in the absence of unacceptable toxicity.

Other: Best Practice; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Aim 1 (QOL-MH); Aim 2 arm I (CBT-C); Aim 2 arm II (SOC)

Best Practice OTHER

Receive SOC

Also known as: standard of care, standard therapy

Aim 2 arm II (SOC)

Cognitive Behavior Therapy BEHAVIORAL

Attend CBT-C sessions

Also known as: CBT, cognitive therapy, CT

Aim 2 arm I (CBT-C)

Questionnaire Administration OTHER

Complete QOL-MH questionnaires

Aim 1 (QOL-MH); Aim 2 arm I (CBT-C); Aim 2 arm II (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18-years
• Stage III-IV melanoma and =\< 2 month duration of this diagnosis
• Able to read English sufficient to complete survey, informed consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Melanoma

Interventions

Practice Guidelines as Topic; Standard of Care; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shawna L. Ehlers, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)