Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
1 other identifier
observational
107
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2017
CompletedFirst Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2020
CompletedDecember 17, 2020
December 1, 2020
3.1 years
October 27, 2017
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
online or telephone survey
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.
Interventions
General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
Eligibility Criteria
The melanoma service has agreed to provide this research team with access to a list of patients who are potentially eligible for this survey.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Korenstein, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
October 31, 2017
Study Start
October 25, 2017
Primary Completion
December 14, 2020
Study Completion
December 14, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12