Long-Term Quality of Life in Patients With Metastatic Melanoma Treated With Checkpoint Inhibitors
NCT ID: NCT03326973
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
107 participants
OBSERVATIONAL
2017-10-25
2020-12-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
EuroQoL EQ-5D-3L
Overall QOL
EORTC QLQ-C30
General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
PRO-CTCAE
Additional potential immune-specific symptoms
Fatigue severity score questionnaire
Fatigue severity
The COST
Financial toxicity; satisfaction with ability to work
Physician information
Details on outside health providers
Interventions
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EuroQoL EQ-5D-3L
Overall QOL
EORTC QLQ-C30
General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
PRO-CTCAE
Additional potential immune-specific symptoms
Fatigue severity score questionnaire
Fatigue severity
The COST
Financial toxicity; satisfaction with ability to work
Physician information
Details on outside health providers
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Deborah Korenstein, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-518
Identifier Type: -
Identifier Source: org_study_id