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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326973
• Other study ID #: 17-518
• Status: Completed
• Start date: October 25, 2017
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Behavioral:
• 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

Other:
• PRO-CTCAE
Additional potential immune-specific symptoms

Behavioral:
• Fatigue severity score questionnaire
Fatigue severity
• The COST
Financial toxicity; satisfaction with ability to work
• Physician information
Details on outside health providers

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memoral Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center