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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01778127
First received: January 18, 2013
Last updated: May 5, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Activity Monitor
Behavioral: Interactive Website
Behavioral: Educational Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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:
  • Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.

  • Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups

  • Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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: Hand Grip [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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: Sit-up [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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: Pushup [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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: Quadriceps at 120 Degrees/Second [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 105
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Behavioral: Activity Monitor
Measurement of physical activity.
Other Names:
  • Tri-Axial Accelerometer
  • Zamzee
Behavioral: 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.
Other Name: Zamzee Website
Behavioral: 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.
Other Name: Educational Brochure
Experimental: Group B: Immediate Incentives

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
Measurement of physical activity.
Other Names:
  • Tri-Axial Accelerometer
  • Zamzee
Behavioral: 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.
Other Name: Zamzee Website
Behavioral: 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.
Other Name: Educational Brochure
Experimental: Group C: Control
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
Measurement of physical activity.
Other Names:
  • Tri-Axial Accelerometer
  • Zamzee
Behavioral: 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.
Other Name: Educational Brochure

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

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778127

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Kirsten K. Ness, PT, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01778127     History of Changes
Other Study ID Numbers: ZAMZEE, NCI-2013-00384
Study First Received: January 18, 2013
Results First Received: April 14, 2015
Last Updated: May 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Cancer Survivor
Physical Activity
Health Outcomes
Rewards-Based Intervention
Cardiovascular Health
Musculoskeletal Health
Exercise

ClinicalTrials.gov processed this record on July 01, 2015