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

Completed

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

• Registration Number: NCT03326973
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-31
• Status Verified: 2020-12
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
online or telephone survey	The COST	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.
online or telephone survey	Physician information	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.
online or telephone survey	EuroQoL EQ-5D-3L	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.
online or telephone survey	EORTC QLQ-C30	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.
online or telephone survey	Fatigue severity score questionnaire	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.
online or telephone survey	PRO-CTCAE	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.

Primary Outcome Measures

Name	Time	Method
total score of Global QOL overall health index	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.

Trial Locations

Locations (6)

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 Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States