Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors

Study Overview
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Brief Summary
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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.

Official Title
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Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Behavioral: EuroQoL EQ-5D-3L
* Behavioral: EORTC QLQ-C30
* Other: PRO-CTCAE
* Behavioral: Fatigue severity score questionnaire
* Behavioral: The COST
* Behavioral: Physician information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| online or telephone survey<br>This is a cross-sectional survey. Our main method of communication with patients will be email. Participants will complete a single online or telephone survey at a minimum of 12 months post initial treatment of checkpoint inhibitors and remain on maintenance therapy. | Behavioral: EuroQoL EQ-5D-3L<br>* Overall QOL<br>Behavioral: EORTC QLQ-C30<br>* General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales<br>Other: PRO-CTCAE<br>* Additional potential immune-specific symptoms<br>Behavioral: Fatigue severity score questionnaire<br>* Fatigue severity<br>Behavioral: The COST<br>* Financial toxicity; satisfaction with ability to work<br>Behavioral: Physician information<br>* Details on outside health providers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total score of Global QOL overall health index | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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17-518, Quality of Life (QoL)