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

St. Jude Children's Research Hospital

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Interactive Website; Behavioral: Educational Materials; Behavioral: Activity Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01778127

ZAMZEE

NCI-2013-00384 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Group A: Minimal Rewards

Experimental group

Description:

Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.

Treatment:

Behavioral: Activity Monitor

Behavioral: Educational Materials

Behavioral: Interactive Website

Group B: Immediate Incentives

Experimental group

Description:

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.

Treatment:

Behavioral: Activity Monitor

Behavioral: Educational Materials

Behavioral: Interactive Website

Group C: Control

Experimental group

Description:

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.

Treatment:

Behavioral: Activity Monitor

Behavioral: Educational Materials