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Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Jun 30, 2026 to Jun 30, 2027 Study sites revised (116)v41 Show 1 more changeShow less
    • Study sites revised (116)

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  2. Primary endpoint revised Secondary endpoints: 12 to 13 · Collaborators: 2 to 1v40 Show 2 more changesShow less
    • Secondary endpoints: 12 to 13
    • Collaborators: 2 to 1

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  3. Enrollment target: estimated 384 to confirmed 387v39
  4. Completion date: Dec 31, 2025 to Jun 30, 2026 Study sites revised (116)v38 Show 1 more changeShow less
    • Study sites revised (116)

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  5. Re-verified, no change to tracked fieldsv37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites revised (116)v36 See this version in full on ClinicalTrials.gov ↗
  2. 2 versions Re-verified since Mar 18, 2025, no change to tracked fieldsv34-v35
  3. Study sites revised (116)v33 See this version in full on ClinicalTrials.gov ↗
  4. Secondary endpoints revised (12) Collaborators revised (2)v32 Show 1 more changeShow less
    • Collaborators revised (2)

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  5. Start date: Oct 26, 2020 to Dec 7, 2020v31
  6. Site details revised at 1 of 116 sitesv30
  7. Trial status: Recruiting to Active, Not Recruiting Study sites: 115 to 116 · Primary and study completion dates: Dec 30, 2025 to Dec 31, 2025v29 Show 2 more changesShow less
    • Study sites: 115 to 116
    • Primary and study completion dates: Dec 30, 2025 to Dec 31, 2025
  8. Site contacts updated at 2 of 115 sitesv28
  9. Study sites: 114 to 115v27
  10. Study sites: 113 to 114v26
  11. Study sites: 111 to 113v25
  12. Study sites: 109 to 111v24
  13. Study sites: 107 to 109v23
  14. Study sites: 101 to 107v22
  15. Study sites: 96 to 101v21
  16. Study sites: 95 to 96v20
  17. Study sites: 93 to 95v19
  18. Study sites: 92 to 93 Eligibility criteria expanded, about 90 words · Collaborators revised (2)v18 Show 2 more changesShow less
    • Eligibility criteria expanded, about 90 words
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 83 to 92v17
  20. Collaborators revised (2)v16 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 70 to 83v15
  22. Study sites: 67 to 70v14
  23. Study sites: 64 to 67v13
  24. Study sites: 61 to 64v12
  25. Study sites: 39 to 61v11
  26. Study sites: 31 to 39v10
  27. Study sites: 13 to 31 Start date changed from estimate of Jan 15, 2021 to Oct 26, 2020v9 Show 1 more changeShow less
    • Start date changed from estimate of Jan 15, 2021 to Oct 26, 2020
  28. Primary endpoints: 3 to 1 Study sites: 1 to 13 · Secondary endpoints: 6 to 12 · Study description revised · 2 morev8 Show 5 more changesShow less
    • Study sites: 1 to 13
    • Secondary endpoints: 6 to 12
    • Study description revised
    • Collaborators: 1 to 2
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  29. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v7 Show 1 more changeShow less
    • Study sites: 0 to 1
  30. Interventions: Educational Intervention (Other), FitBit (Device), Goal Setting (Other), Media Intervention (Other), Telephone-Based Intervention… to Educational Intervention (Other), FitBit (Device), Goal Setting (Other), Health Promotion and Education (Other), Media Intervention… Eligibility criteria expanded, about 22 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  31. Re-verified, no change to tracked fieldsv5
  32. Interventions: PA Tracker (Behavioral), Social Media (Behavioral) to Educational Intervention (Other), FitBit (Device), Goal Setting (Other), Media Intervention (Other), Telephone-Based Intervention… Secondary endpoints revised (6) · Primary endpoints revised (3) · Study title shortened, about 6 words · 2 morev4 Show 5 more changesShow less
    • Secondary endpoints revised (6)
    • Primary endpoints revised (3)
    • Study title shortened, about 6 words
    • Eligibility criteria shortened, about 3 words
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  33. Phase: Not applicable to Phase 3 Lead sponsor: Yale University to Children's Oncology Group · Primary completion date: Sep 30, 2023 to Dec 30, 2025 · Start date: Jun 30, 2020 to Jan 15, 2021 · 4 morev3 Show 7 more changesShow less
    • Lead sponsor: Yale University to Children's Oncology Group
    • Primary completion date: Sep 30, 2023 to Dec 30, 2025
    • Start date: Jun 30, 2020 to Jan 15, 2021
    • Completion date: Sep 30, 2024 to Dec 30, 2025
    • Eligibility criteria expanded, about 144 words
    • Study description expanded, about 96 words
    • Study title expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  34. Start date: Sep 30, 2019 to Jun 30, 2020v2
  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 a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
Trial Details
NCT Number NCT04089358
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Enrollment 387 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov