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
Purpose
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.
Condition
- Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
Experimental Aim 2 arm I (CBT-C) |
Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity. |
|
|
Active Comparator Aim 2 arm II (SOC) |
Patients receive SOC for 6 weeks in the absence of unacceptable toxicity. |
|
Recruiting Locations
Rochester 5043473, Minnesota 5037779 55905
More Details
- NCT ID
- NCT07379138
- Status
- Recruiting
- Sponsor
- Mayo Clinic