Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
University of Rochester
Summary
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.
Description
PRIMARY OBJECTIVE: I. To assess the efficacy of GEM-S for improving patient-reported physical function (Functional Assessment of Chronic Illness-Fatigue Physical Well-Being Subscale \[FACIT-PWB\]) in older cancer survivors at 6 months. (Survivor Aim) SECONDARY OBJECTIVE: I. To assess the efficacy of GEM-S for improving patient-reported cognitive function (Functional Assessment of Cancer Therapy \[FACT\]-cognitive function \[Cog\]) in older cancer survivors at 6 months. TERTIARY OBJECTIVES: I. To assess the preliminary efficacy of GEM-S for improving: Ia. Objective physical function (6-mi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * PRACTICE CRITERIA: Participating practice clusters will be required to identify one (or more) oncologist and/or advanced practice practitioner (APPs; i.e., nurse practitioners, or physician assistants) as part of study eligibility. If another clinician is interested in participating, please contact University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) for approval * Oncologists/APPs/other clinicians must be licensed to practice * Oncologists/APPs/other clinicians must not have a plan to…
Interventions
- OtherBest Practice
Receive usual follow-up survivorship care
- OtherComprehensive Geriatric Assessment
Complete geriatric assessment
- OtherEducational Intervention
Participate in survivorship health education sessions
- OtherExercise Intervention
Participate in SHE-EXCAP program
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureTailored Intervention
Participate in GEM consultation
Locations (45)
- Lewis and Faye Manderson Cancer CenterTuscaloosa, Alabama
- Kaiser Permanente-FremontFremont, California
- Kaiser Permanente-San FranciscoSan Francisco, California
- Helen F Graham Cancer CenterNewark, Delaware
- Medical Oncology Hematology Consultants PANewark, Delaware
- Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, Hawaii