Clinical trial NCT01778127: A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
Official title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer Survivor
Physical Activity
Health Outcomes
Rewards-Based Intervention
Cardiovascular Health
Musculoskeletal Health
Exercise
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 105
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
timeFrame: Baseline and 24 weeks
measure: Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten K. Ness, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: