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OpenTrials
Completed

NCT Number: NCT03326973

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.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memoral Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EuroQoL EQ-5D-3L

Behavioral

Overall QOL

EORTC QLQ-C30

Behavioral

General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales

PRO-CTCAE

Other

Additional potential immune-specific symptoms

Fatigue severity score questionnaire

Behavioral

Fatigue severity

The COST

Behavioral

Financial toxicity; satisfaction with ability to work

Physician information

Behavioral

Details on outside health providers

Primary outcomes

  1. total score of Global QOL overall health index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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