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


N/A
11 Years
14 Years
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in daily average of moderate and vigorous physical activity (MVPA) levels between groups

Outcome Description:

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.

Outcome Time Frame:

Baseline, Week 12 and Week 24

Safety Issue:

No

Principal Investigator

Kirsten K. Ness, PT, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

ZAMZEE

NCT ID:

NCT01778127

Start Date:

February 2013

Completion Date:

January 2016

Related Keywords:

  • Cancer
  • Cancer Survivor
  • Physical Activity
  • Health Outcomes
  • Rewards-Based Intervention
  • Cardiovascular Health
  • Musculoskeletal Health
  • Exercise

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794