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NCT04089358 · ClinicalTrials.gov registry record · Phase 3
Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study
A Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 387
- Enrollment target
- 20
- Study locations
NCT04089358: Active Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Children's Oncology Group.
NCT04089358 is a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 387 participants, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089358, a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 387 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence int
Conditions Studied
Interventions
- OTHER Educational Intervention
- OTHER Goal Setting
- OTHER Media Intervention
- OTHER Health Promotion and Education
- DEVICE FitBit
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
- Santa Barbara Cottage Hospital - Santa Barbara
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Alabama
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04089358 still lists
NCT04089358 is an interventional study that assigns participants to a tested intervention. The registered 387 participants enrollment target is mid-sized for trials with a published cap, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Educational Intervention is the first listed.
NCT04089358 names 20 study sites across 7 states, led by California, Connecticut, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04089358 about?
NCT04089358 is a clinical study titled "Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study". 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 heal...
What is the current status of trial NCT04089358?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 387 participants. The study started on 2020-12-07. Estimated completion is 2026-06-30.
What conditions does trial NCT04089358 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT04089358?
The interventions under investigation include: Educational Intervention (OTHER), Goal Setting (OTHER), Media Intervention (OTHER), Health Promotion and Education (OTHER), FitBit (DEVICE).
Who is sponsoring clinical trial NCT04089358?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04089358 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04089358's enrollment target sits among peer trials
387 40th of 176 higher than 137 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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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