Clinical trial · Interventional
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
Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Cognitive Behavior Therapy | Behavioral | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aim 1 (QOL-MH)
- description
- 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.
- interventionNames
- Other: Electronic Health Record Review
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Aim 2 arm I (CBT-C)
- description
- Patients attend CBT-C sessions once a week for 6 weeks in the absence of unacceptable toxicity.
- interventionNames
- Behavioral: Cognitive Behavior Therapy
- Other: Electronic Health Record Review
- Other: Questionnaire Administration
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available