A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Activity Monitor
* Behavioral: Interactive Website
* Behavioral: Educational Materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Minimal Rewards<br>Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. | Behavioral: Activity Monitor<br>* Measurement of physical activity.<br>* Other names: Zamzee;Behavioral: Interactive Website<br>* 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.<br>* Other names: Zamzee Website;Behavioral: Educational Materials<br>* 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.<br>* Other names: Educational Brochure;|
| Experimental: Group B: Immediate Incentives<br>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<br>* Measurement of physical activity.<br>* Other names: Zamzee;Behavioral: Interactive Website<br>* 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.<br>* Other names: Zamzee Website;Behavioral: Educational Materials<br>* 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.<br>* Other names: Educational Brochure;|
| Experimental: Group C: Control<br>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<br>* Measurement of physical activity.<br>* Other names: Zamzee;Behavioral: Educational Materials<br>* 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.<br>* Other names: Educational Brochure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups | Baseline and 24 weeks | 
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups. | Baseline and 24 weeks | 
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups. | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivor, Physical Activity, Health Outcomes, Rewards-Based Intervention, Cardiovascular Health, Musculoskeletal Health, Exercise