Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial

Conditions

• Lymphoma
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Best Practice — OTHER
  Receive usual follow-up survivorship care
• Comprehensive Geriatric Assessment — OTHER
  Complete geriatric assessment
• Educational Intervention — OTHER
  Participate in survivorship health education sessions
• Exercise Intervention — OTHER
  Participate in SHE-EXCAP program
• Questionnaire Administration — OTHER
  Ancillary studies
• Tailored Intervention — PROCEDURE
  Participate in GEM consultation

Study Details

This phase III trial compares the effect of geriatric evaluation and management with survivorship health education (GEM-S) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEM-S may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEM-S in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

Key Dates

Start date

Mar 21, 2023

Status verified

Jan 2026

Primary completion

May 17, 2027

Completion

Sep 17, 2027

Study Design

Enrollment

668 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Arm I (usual care)
  Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.
• Experimental: Arm II (GEMS intervention)
  Survivors and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Both survivors and caregivers also participate in SHE sessions over 75 minutes twice weekly for 4 weeks. Survivors and caregivers also participate in EXCAP program, which includes daily walking and resistance exercises.

Primary Outcome Measure

Patient-reported physical function [ Time Frame: Up to 6 months ]

Locations (45)

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