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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT03326973

Collaborator

(none)

107

Enrollment

Locations

37.7

Actual Duration (Months)

17.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Behavioral: EuroQoL EQ-5D-3L Behavioral: EORTC QLQ-C30 Other: PRO-CTCAE Behavioral: Fatigue severity score questionnaire Behavioral: The COST Behavioral: Physician information

Study Design

Study Type:

Observational

Actual Enrollment :

107 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 25, 2017

Actual Primary Completion Date :

Dec 14, 2020

Actual Study Completion Date :

Dec 14, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
4	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT03326973

Other Study ID Numbers:

17-518

First Posted:

Oct 31, 2017

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Quality of Life (QoL)

17-518

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Dec 17, 2020