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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Behavioral: EuroQoL EQ-5D-3L; Behavioral: EORTC QLQ-C30; Other: PRO-CTCAE; Behavioral: Fatigue severity score questionnaire; Behavioral: The COST; Behavioral: Physician information

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memoral Sloan Kettering Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memoral Sloan Kettering Monmouth
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Rockville Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The melanoma service has agreed to provide this research team with access to a list of patients who are potentially eligible for this survey.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: EuroQoL EQ-5D-3L; Overall QOL; Behavioral: EORTC QLQ-C30; General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales; Other: PRO-CTCAE; Additional potential immune-specific symptoms; Behavioral: Fatigue severity score questionnaire; Fatigue severity; Behavioral: The COST; Financial toxicity; satisfaction with ability to work; Behavioral: Physician information; Details on outside health providers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Deborah Korenstein, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life (QoL); 17-518
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 17-518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No