Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 43 days later Feb 22, 2026 → Apr 6, 2026
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Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Feb 22, 2026 to Apr 6, 2026
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 14 of 14 entries
    • Publications: details revised at 36 of 51 entries
  2. Minor Secondary endpoints: 37 to 14v19
  3. Minor Study completion date: Feb 22, 2026 to Dec 31, 2026v18
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Dec 31, 2025 to Feb 22, 2026
    • Site details revised at 2 of 2 sites
    v17
  5. 2 versions Re-verified since Jul 26, 2024, no change to tracked fieldsv15-v16
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Study description shortened, about 6 wordsv14
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 26, 2023 to Jul 18, 2023
    • Site details revised at 2 of 2 sites
    v13
  3. Minor Primary and study completion dates: Sep 30, 2025 to Dec 31, 2025
    • Start date: Jun 19, 2023 to Jun 26, 2023
    v12
  4. Minor Secondary endpoints: 32 to 37
    • Study description shortened, about 36 words
    v11
  5. Notable Start date: May 15, 2023 to Jun 19, 2023v10
  6. Minor Start date: May 8, 2023 to May 15, 2023v9
  7. Notable Start date: Apr 3, 2023 to May 8, 2023v8
  8. Notable Start date: Mar 1, 2023 to Apr 3, 2023v7
  9. Minor Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025v6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints: 26 to 32
    • Study description shortened, about 12 words
    • Study title expanded, about 1 word
  10. Notable Start date: Jan 15, 2023 to Mar 1, 2023v5
  11. Notable Start date: Nov 1, 2022 to Jan 15, 2023v4
  12. Notable Start date: Aug 1, 2022 to Nov 1, 2022v3
  13. Minor Secondary endpoints: 25 to 26v2
  1. 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 purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden. PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.
Trial Details
NCT Number NCT05375162
Lead Sponsor Northwestern University
Collaborators: National Cancer Institute (NCI), Wake Forest University Health Sciences
Conditions
(from sponsor)
Cancer
Related terms Motor Activity, Neoplasms
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov