A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Behavioral: Activity Monitor Behavioral: Interactive Website Behavioral: Educational Materials |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer |
- Change in daily average of moderate and vigorous physical activity (MVPA) levels between groups [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]The impact of the intervention will be assessed at the end of 24 weeks by comparing physical activity levels at baseline, week 12, and week 24 in each group. Data will be collected each time a participant accesses the website (or connects the accelerometer - for the control group) over the entire 24 week period, resulting in access to data on daily levels of physical activity over a 24 week period.
- Change in cardiovascular function between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]VO2 max will be used as the marker for physical fitness. Differences between groups will be evaluated with an F-test.
- Change in muscular strength between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]Means and standard deviations and the estimated change in grip strength (kilograms), knee extension strength 60 degrees per second (Newton meters), ankle dorsiflexion strength 30 degrees per second (Newton meters), and strength subtest (Bruininks-Oseretsky Test of Motor Proficiency) will be compared between baseline and 24 weeks.
- Change in flexibility between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]Means and standard deviations of active plantar flexion, active dorsiflexion, and sit and reach will be compared between baseline and 24 weeks.
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
|
Behavioral: Activity Monitor
Measurement of physical activity.
Other Names:
Behavioral: Interactive Website
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.
Other Name: Zamzee Website
Behavioral: Educational Materials
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.
Other Name: Educational Brochure
|
|
Experimental: Group B: Immediate Incentives
Participants 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. |
Behavioral: Activity Monitor
Measurement of physical activity.
Other Names:
Behavioral: Interactive Website
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.
Other Name: Zamzee Website
Behavioral: Educational Materials
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.
Other Name: Educational Brochure
|
|
Experimental: Group C: Control
Participants 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.
|
Behavioral: Activity Monitor
Measurement of physical activity.
Other Names:
Behavioral: Educational Materials
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.
Other Name: Educational Brochure
|
Detailed Description:
PRIMARY OBJECTIVE:
- To compare changes in levels of moderate and vigorous physical activity over 24 weeks.
SECONDARY OBJECTIVE:
- To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.
Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.
After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.
Eligibility| Ages Eligible for Study: | 11 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
- 11 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)
Exclusion Criteria:
- Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
- Pregnant female
- Inability to read and write English
Contacts and Locations| Contact: Kirsten K. Ness, PT, PhD | 866-278-5833 | info@stjude.org |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Kirsten K. Ness, PT, PhD 866-278-5833 info@stjude.org | |
| Principal Investigator: Kirsten K. Ness, PT, PhD | |
| Principal Investigator: | Kirsten K. Ness, PT, PhD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01778127 History of Changes |
| Other Study ID Numbers: | ZAMZEE, 1 R21HD077235 |
| Study First Received: | January 18, 2013 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
|
Cancer Survivor Physical Activity Health Outcomes Rewards-Based Intervention |
Cardiovascular Health Musculoskeletal Health Exercise |
ClinicalTrials.gov processed this record on May 23, 2013