A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Sponsor:

ECOG-ACRIN Cancer Research Group

Sponsor Study ID:

EA6244

CTO #:

104360

NCT Number:

NCT07068074

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Melanoma, Skin

Study Objectives:

Patient-Reported Outcome (PRO) Component [Time Frame: (FACT-M) baseline 4 months 8 months 12 months 16 months 20 months 24 months] The patient reported outcomes (PRO) in this study include a Geriatric Assessment (GA) and the FACT-M Quality of Life (QOL). The National Comprehensive Cancer Network (NCCN) guidelines advocate geriatric assessment (GA) for older patients with cancer to identify health status issues that increase the risk of adverse outcomes. A GA evaluates comorbidity, functional status, physical performance, cognitive ability, psychological status, medications and social support with standardized tools that predict morbidity and mortality in community-dwelling vulnerable older adults. Benefits of GA in community-dwelling vulnerable older adults include prevention of geriatric syndromes, recognition of cognitive deficits, addressing geriatric abnormalities detected by the assessment to prevent hospitalizations and nursing home admissions, and overall improvement of quality of life.

eConsent:

Not available

Study Documents:

Open Study Documents
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