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

Not Applicable

Completed

Conditions: Cancer

Interventions: Behavioral: Activity Monitor
Behavioral: Interactive Website
Behavioral: Educational Materials

Registration Number: NCT01778127

Lead Sponsor: St. Jude Children's Research Hospital

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Minimal Rewards	Interactive Website	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Group B: Immediate Incentives	Educational Materials	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.
Group B: Immediate Incentives	Interactive Website	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.
Group C: Control	Activity Monitor	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.
Group A: Minimal Rewards	Activity Monitor	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Group A: Minimal Rewards	Educational Materials	Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Group B: Immediate Incentives	Activity Monitor	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.
Group C: Control	Educational Materials	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.

Primary Outcome Measures

Name	Time	Method
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups	Baseline, Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up	Baseline and 24 weeks	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.
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second	Baseline and 24 weeks	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
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second	Baseline and 24 weeks	The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks	Baseline and 24 weeks	The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip	Baseline and 24 weeks	The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup	Baseline and 24 weeks	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.
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach	Baseline and 24 weeks	The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second	Baseline and 24 weeks	The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion	Baseline and 24 weeks	The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second	Baseline and 24 weeks	The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second	Baseline and 24 weeks	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.