Metastatic Melanoma
Conditions
Keywords
Quality of Life (QoL), 17-518
Brief summary
To identify and describe long-term quality of life (QOL) issues in patients with metastatic melanoma treated with checkpoint inhibitors who achieved cancer control for a minimum of 12 months and remain on maintenance checkpoint inhibitor therapy.
Interventions
BEHAVIORALEuroQoL EQ-5D-3L
Overall QOL
BEHAVIORALEORTC QLQ-C30
General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
OTHERPRO-CTCAE
Additional potential immune-specific symptoms
BEHAVIORALFatigue severity score questionnaire
Fatigue severity
BEHAVIORALThe COST
Financial toxicity; satisfaction with ability to work
BEHAVIORALPhysician information
Details on outside health providers
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to speak and read English * Be able to provide informed consent * Have been diagnosed with metastatic melanoma at age 18 years or older * Have been treated with either single agent or combination checkpoint inhibitor * Be at least 12 months since first dose of above named agents * Received no other systemic therapy after initiation of immunotherapy (interval radiation or surgery will be permitted based on review with primary treating medical oncologist)
Exclusion criteria
* Patients with cognitive, visual, or motor impairment such that they cannot complete the survey as assessed by the research or clinical team * Patients who developed a subsequent cancer after starting on checkpoint inhibitor(s), exclusive of non-melanoma superficial skin cancers * Patients with clinical documentation of progressive disease on the most recent assessment in the electronic medical record * Patients with symptomatic progression but continue on immunotherapy * Note: For any patients where the disease status is not clear, we will confirm that the disease is either stable or responsive with their primary treating medical oncologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total score of Global QOL overall health index | 1 year | On the EQ-5D-3L, respondents are asked to indicate their health state by marking the box associated with the most appropriate statement in each of the 5 dimensions, resulting in a one digit number expressing the level (1-3) selected for that dimension from no problems to extreme problems. |
Countries
United States
Outcome results
None listed