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

Study acronym: GEM-S
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: May 17, 2027 to Sep 17, 2027
    • Start date: Jul 18, 2023 to Mar 21, 2023
    v14
  2. Phase: Not applicable to Phase 3v13 Show 10 more changesShow less
    • Lead sponsor: University of Rochester NCORP Research Base to University of Rochester
    • Enrollment target: 960 to 668
    • Primary completion date: Jun 1, 2028 to May 17, 2027
    • Primary endpoint revised
    • Study sites: 12 to 45
    • Study completion date: Dec 31, 2028 to May 17, 2027
    • Eligibility criteria expanded, about 220 words
    • Secondary endpoint revised
    • Study description expanded, about 173 words
    • Study title expanded, about 1 word
  3. Study sites: 11 to 12v12
  4. Primary completion date: Dec 15, 2027 to Jun 1, 2028
    • Study completion date: Dec 15, 2028 to Dec 31, 2028
    v11
  5. Primary completion date: Dec 31, 2026 to Dec 15, 2027v10 Show 4 more changesShow less
    • Study sites: 3 to 11
    • Study completion date: Dec 31, 2027 to Dec 15, 2028
    • Eligibility criteria shortened, about 26 words
    • Study description revised
Show 8 earlier versionsHide 8 earlier versions
  1. Start date changed from estimate of May 31, 2023 to Jul 18, 2023v9
  2. Primary completion date: Jan 1, 2026 to Dec 31, 2026
    • Start date: Jan 13, 2023 to May 31, 2023
    • Study completion date: Jul 30, 2026 to Dec 31, 2027
    v8
  3. Enrollment target: 780 to 960
    • Eligibility criteria revised
    • Study description shortened, about 4 words
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 15, 2023 to Jan 13, 2023
    v6
  5. Start date: Apr 25, 2022 to Jan 15, 2023v5
  6. Start date: Feb 1, 2022 to Apr 25, 2022v4
  7. Start date: Oct 1, 2021 to Feb 1, 2022v3
  8. Primary endpoint revised
    • Secondary endpoint revised
    • Study description revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05006482
Lead Sponsor University of Rochester
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Lymphoma, Malignant Solid Neoplasm
Related terms Lymphoma
Enrollment 668 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov