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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Metastatic Melanoma

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

Study type: Observational

Funder types: Other

Identifiers

NCT03326973

17-518

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

107 participants in 1 patient group

online or telephone survey

Description:

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.

Treatment:

Behavioral: EORTC QLQ-C30

Behavioral: Fatigue severity score questionnaire

Behavioral: The COST

Behavioral: Physician information

Other: PRO-CTCAE

Behavioral: EuroQoL EQ-5D-3L