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Recruiting NCT07379138

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

No phase Interventional Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Cognitive Behavior Therapy, Electronic Health Record Review, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Change in PHQ-8 score [Time frame: 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]
  • Change in PSQI score [Time frame: 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]
  • Change in PROMIS: Pain Interference score [Time frame: 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]
  • Change in MEPS score [Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07379138 · 25-007199 · HT9425-25-1-0802

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗