Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 7 of 13 entries
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Site contact updatedv5
  4. Minor Primary completion date: Aug 2028 to Aug 1, 2028
    • Study completion date: Aug 2029 to Aug 1, 2029
    v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2023 to Sep 15, 2023
    • Site details revised
    v3
  6. Notable Primary endpoint revised
    • Secondary endpoints: 9 to 13
    v2
  7. Minor Study First Submitted
  • 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.
The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.
Trial Details
NCT Number NCT05743517
Lead Sponsor Northwestern University
Conditions
(from sponsor)
Ovary Cancer, Endometrial Cancer, Uterine Cancer, Cervical Cancer, Cervix Cancer, Vulvar Cancer, Vaginal Cancer
Related terms Endometrial Neoplasms, Motor Activity, Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov