Studying Quality of Life and CBT for Melanoma Patients
This study is looking at how people with advanced melanoma (stage III-IV) feel and live during the first two years after their diagnosis. It aims to see if a type of talk therapy called Cognitive Behavioral Therapy for Cancer Distress (CBT-C) can improve their overall quality of life, including their mental health. As more people are surviving melanoma due to new treatments, understanding and improving their well-being is very important. CBT-C helps you change how you think and feel about things to improve your behavior. You might be able to join if you are at least 18 years old, have stage III-IV melanoma diagnosed within the last two months, and can read English. The study plans to enroll 350 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 350 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would complete questionnaires about your quality of life and mental health at the start of the study, and then at 3, 6, 9, 12, 18, and 24 months. Some participants will also attend CBT-C sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life and mental health will be tracked for up to 24 months after enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shawna L. Ehlers, PhD, LP · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Change in FACT-M total score (Aim 1)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.
- Change in FACT-ICM total score (Aim 1)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.
- Change in Impact of Events Scale-Revised (IES-R) score (Aim 1)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.
- Change in IES-R score (Aim 2)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.