A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
2 other identifiers
interventional
105
1 country
1
Brief Summary
Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity. Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 29, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
May 21, 2015
CompletedMay 21, 2015
April 1, 2015
1.2 years
January 18, 2013
April 14, 2015
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.
Baseline, Week 24
Secondary Outcomes (11)
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
Baseline and 24 weeks
- +6 more secondary outcomes
Study Arms (3)
Group A: Minimal Rewards
EXPERIMENTALParticipants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Group B: Immediate Incentives
EXPERIMENTALParticipants use an activity monitor and the interactive website. In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
Group C: Control
EXPERIMENTALParticipants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
Interventions
Measurement of physical activity.
Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
Eligibility Criteria
You may qualify if:
- Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
- through 14 years of age
- Not undergoing active treatment for cancer
- Medical clearance from participant's attending physician via email
- Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week
- Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)
You may not qualify if:
- Global cognitive impairment (Full Scale Intelligence Quotient \< 70) that prevents use of the interactive website
- Pregnant female
- Inability to read and write English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kirsten K. Ness, PT, PhD
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kirsten K. Ness, PT, PhD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2013
First Posted
January 29, 2013
Study Start
February 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 21, 2015
Results First Posted
May 21, 2015
Record last verified: 2015-04