N/A
N=49
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
Survivorship · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT02688192 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Feasibility of the Technology-enhanced Fitness Program — 25; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Intervention (Behavioral); Internet-Based Intervention (Behavioral); Monitoring Device (Device); Quality-of-Life Assessment (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Technology-enhanced Fitness Program |
25; 24 | — |
| SECONDARY Feasibility - Retention |
15; 22 | — |
| SECONDARY Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale |
60.12; 71.02; 65.18; 71.40; 55.95; 62.88 | 0.39 |
| SECONDARY Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale |
72.10; 79.75; 74.11; 81.68; 72.64; 77.92 | .98 |
| SECONDARY Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test |
36.67; 40.61; 39.08; 39.80 | .29 |
| SECONDARY Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) |
191.93; 199.78; 247.23; 219.71; 35.78; 45.51 | .019 sig |
| SECONDARY Feasibility - Engagement With the App |
6.50; 165.48; 8.50; 0.62 | — |
Summary
This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions. A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality. Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life. Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood. A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.
Eligibility Criteria
Inclusion Criteria
- Any diagnosis of cancer prior to age 21
- Off treatment for at least 6 months
- For patients = 18 must give informed consent
Exclusion Criteria
- Any medical contraindication to exercise according to a physician or physician's designee
- Non-English speaking
- Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children = 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating
- Significant developmental delay per patient, parent, or physician report
- Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation
Data sourced from ClinicalTrials.gov (NCT02688192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.