Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)
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.
Arms & interventions
- OtherBest Practice
Receive SOC
- BehavioralCognitive Behavior Therapy
Attend CBT-C sessions
- OtherElectronic Health Record Review
Ancillary studies
- OtherQuestionnaire Administration
Complete QOL-MH questionnaires
Outcome measures
Primary
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: Baseline (at enrollment) and 3, 6, 9, 12, 18, and 24 months
Secondary
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
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905