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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778127
• Other study ID #: ZAMZEE
• Secondary ID: NCI-2013-00384
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: May 5, 2015
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Activity Monitor
Measurement of physical activity.
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital