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NCT05006482 · ClinicalTrials.gov registry record · Phase 3
Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
A Phase 3 study of Lymphoma and Malignant Solid Neoplasm, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 668
- Enrollment target
- 20
- Study locations
NCT05006482: Recruiting Phase 3 study of Lymphoma and Malignant Solid Neoplasm, sponsored by University of Rochester.
NCT05006482 is a Phase 3 study of Lymphoma and Malignant Solid Neoplasm that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 668 participants, above the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05006482, a Phase 3 study of Lymphoma and Malignant Solid Neoplasm, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 668 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Will be assessed by the Functional Assessment of Cancer Therapy Physical Well-Being (FACIT-PWB) Subscale in older cancer survivors. The FACIT-PWB is 7-items as part of a larger 40-item FACIT-F questionnaire. Each question uses a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much).
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- OTHER Exercise Intervention
- OTHER Best Practice
- OTHER Educational Intervention
- OTHER Comprehensive Geriatric Assessment
Study Locations (20)
Minnesota
- Fairview Southdale Hospital - Edina
- Hennepin County Medical Center - Minneapolis
- Monticello Cancer Center - Monticello
- Park Nicollet Clinic - Saint Louis Park - Saint Louis Park
- Regions Hospital - Saint Paul
- Lakeview Hospital - Stillwater
- Rice Memorial Hospital - Willmar
- Minnesota Oncology Hematology PA-Woodbury - Woodbury
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Straub Clinic and Hospital - Honolulu
- Kapiolani Medical Center for Women and Children - Honolulu
- Tripler Army Medical Center - Honolulu
- Hawaii Cancer Care - Westridge - ‘Aiea
- Pali Momi Medical Center - ‘Aiea
California
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-San Francisco - San Francisco
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Alabama
- Lewis and Faye Manderson Cancer Center - Tuscaloosa
Illinois
- OSF Saint Anthony's Health Center - Alton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2027-09-17 |
| Phase | Phase 3 |
What NCT05006482 shows while recruiting
NCT05006482 is an interventional study that assigns participants to a tested intervention. The registered 668 participants enrollment target is mid-sized for trials with a published cap, above the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (39% higher).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Questionnaire Administration is the first listed.
NCT05006482 names 20 study sites across 6 states, led by Minnesota, Hawaii, California.
Frequently Asked Questions
What is clinical trial NCT05006482 about?
NCT05006482 is a clinical study titled "Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial". 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 doct...
What is the current status of trial NCT05006482?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2023-03-21. Estimated completion is 2027-09-17.
What conditions does trial NCT05006482 study?
This clinical trial studies the following conditions: Lymphoma, Malignant Solid Neoplasm.
What interventions are being tested in trial NCT05006482?
The interventions under investigation include: Questionnaire Administration (OTHER), Exercise Intervention (OTHER), Best Practice (OTHER), Educational Intervention (OTHER), Comprehensive Geriatric Assessment (OTHER).
Who is sponsoring clinical trial NCT05006482?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05006482 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05006482's enrollment target sits among peer trials
668 11th of 299 higher than 289 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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