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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00384 | Registry Identifier | NCI Clinical Trial Registration Program |
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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.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Minimal Rewards | Experimental | Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. |
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| Group B: Immediate Incentives | Experimental | 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 C: Control | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity Monitor | Behavioral | Measurement of physical activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten K. Ness, PT, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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98 participants were randomized 1:1:1 stratified by gender into 3 groups. Randomization was implemented using software based on Zelen's methodology. The principal investigator and study staff were blind to group assignment.
This protocol enrolled 105 participants at St. Jude Children's Research Hospital from 9/2013 through 4/2014. Of the 105, 5 were determined to be ineligible after baseline screening (4 too active; 1 did not meet IQ criteria), and 2 withdrew prior to randomization but after baseline testing. The remaining 98 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Minimal Rewards | Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. 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. |
| FG001 | 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. 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. |
| FG002 | 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. Activity Monitor: Measurement of physical activity. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Minimal Rewards | Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 24 |
|
Adverse events were collected from the on-study date until the completion of the intervention up to 24 weeks later.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Minimal Rewards | Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal ECG | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Two children had abnormal ECG findings on their baseline cardiopulmonary fitness tests and were referred to their primary care physician. Neither was related to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten K. Ness, PT, PhD | St. Jude Children's Research Hospital | 901-595-5157 | kiri.ness@stjude.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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|
| Interactive Website | 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 | 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. |
|
|
The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups |
| Baseline and 24 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | 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. 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. |
| BG002 | 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. Activity Monitor: Measurement of physical activity. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Diagnosis | Number | participants |
|
| Daily Moderate to Vigorous Physical Activity (MVPA) | Mean | Standard Deviation | minutes |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Resting heart rate (HR) | Mean | Standard Deviation | beats/minute |
|
| Resting respiratory rate (RR) | Mean | Standard Deviation | breaths/minute |
|
| Blood pressure (BP) | Mean | Standard Deviation | mmHG |
|
| Peak VO2 | Peak VO2 is a measure of exercise capacity: volume of oxygen uptake per minute adjusted for weight. | Mean | Standard Deviation | ml/kg/min |
|
| Sit and reach | Sit and reach is a measure of low back and hamstring flexibility. | Mean | Standard Deviation | cm |
|
| Active dorsiflexion | Active dorsiflexion is a measure of ankle flexibility. | Mean | Standard Deviation | degrees |
|
| Hand grip | Hand grip is a measure of how much muscle power a person can generate gripping an object. | Mean | Standard Deviation | kg |
|
| Sit-up | This measure assessed the number of sit-ups done in 30 seconds. | Mean | Standard Deviation | sit-ups |
|
| Pushup | This measure assessed the number of push-ups done in 30 seconds. | Mean | Standard Deviation | push-ups |
|
| Quadriceps | Mean | Standard Deviation | Newton meters (Nm)/kg |
|
| Dorsiflexion | Mean | Standard Deviation | Nm/kg |
|
| OG001 | 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. 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. |
| OG002 | 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. Activity Monitor: Measurement of physical activity. 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline and 24 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | cm | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | kg | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Sit-ups | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Pushups | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Newton meters (Nm)/kg | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Nm/kg | Baseline and 24 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | Nm/kg | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Nm/kg | Baseline and 24 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Nm/kg | Baseline and 24 weeks |
|
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | 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. 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. | 0 | 31 | 0 | 31 |
| EG002 | 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. Activity Monitor: Measurement of physical activity. 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. | 0 | 26 | 0 | 26 |
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| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.37 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.09 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.89 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.99 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.59 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.83 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.99 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.54 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.81 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.83 | 2-Sided | No | Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.81 | 2-Sided | No | Superiority or Other |