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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01778127
First received: January 18, 2013
Last updated: March 12, 2014
Last verified: March 2014
  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:
  • Change in daily average of moderate and vigorous physical activity (MVPA) levels between groups [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The impact of the intervention will be assessed at the end of 24 weeks by comparing physical activity levels at baseline, week 12, and week 24 in each group. Data will be collected each time a participant accesses the website (or connects the accelerometer - for the control group) over the entire 24 week period, resulting in access to data on daily levels of physical activity over a 24 week period.


Secondary Outcome Measures:
  • Change in cardiovascular function between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    VO2 max will be used as the marker for physical fitness. Differences between groups will be evaluated with an F-test.

  • Change in muscular strength between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Means and standard deviations and the estimated change in grip strength (kilograms), knee extension strength 60 degrees per second (Newton meters), ankle dorsiflexion strength 30 degrees per second (Newton meters), and strength subtest (Bruininks-Oseretsky Test of Motor Proficiency) will be compared between baseline and 24 weeks.

  • Change in flexibility between groups over 24 weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Means and standard deviations of active plantar flexion, active dorsiflexion, and sit and reach will be compared between baseline and 24 weeks.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated 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

Contacts
Contact: Kirsten K. Ness, PT, PhD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Kirsten K. Ness, PT, PhD    866-278-5833    info@stjude.org   
Principal Investigator: Kirsten K. Ness, PT, PhD         
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
Study First Received: January 18, 2013
Last Updated: March 12, 2014
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 20, 2014