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

NCT ID: NCT01778127

Last Updated: 2015-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group A: Minimal Rewards

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

Group Type EXPERIMENTAL

Activity Monitor

Intervention Type BEHAVIORAL

Measurement of physical activity.

Interactive Website

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Activity Monitor

Intervention Type BEHAVIORAL

Measurement of physical activity.

Interactive Website

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Activity Monitor

Intervention Type BEHAVIORAL

Measurement of physical activity.

Educational Materials

Intervention Type BEHAVIORAL

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.

Interventions

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Activity Monitor

Measurement of physical activity.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Tri-Axial Accelerometer Zamzee Zamzee Website Educational Brochure

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten K. Ness, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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NCI-2013-00384

Identifier Type: REGISTRY

Identifier Source: secondary_id

ZAMZEE

Identifier Type: -

Identifier Source: org_study_id

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