An interventional study of Activity Monitor and Interactive Website in Cancer, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 11 Years to 14 Years. Per ClinicalTrials.gov, last updated 2015-05-21.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Supportive care
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.
St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
Behavioral: Activity Monitor · Behavioral: Interactive Website · Behavioral: Educational Materials
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 · Behavioral: Interactive Website · Behavioral: Educational Materials
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 · Behavioral: Educational Materials
Measurement of physical activity.
Also known as: Tri-Axial Accelerometer, Zamzee
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.
Also known as: Zamzee Website
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.
Also known as: Educational Brochure
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.
Time frame: Baseline, Week 24
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.
Time frame: Baseline and 24 weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 24 weeks
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.
| Milestone | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Started | 33 | 33 | 32 |
| Completed | 25 | 31 | 26 |
| Not completed | 8 | 2 | 6 |
| Withdrew: Lost to follow-up | 5 | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 1 | 4 |
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.
| minutes | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups | -2.58 ± 13.70 | -2.12 ± 12.95 | -7.78 ± 13.70 |
The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.
| ml/kg/min | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks | -0.21 ± 5.15 | -1.19 ± 4.70 | 0.09 ± 5.25 |
The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups
| cm | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach | -0.71 ± 4.85 | 2.25 ± 4.50 | -0.02 ± 4.85 |
The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.
| degrees | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion | -1.72 ± 6.40 | -0.55 ± 5.70 | -0.32 ± 6.25 |
The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.
| kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip | 1.47 ± 3.50 | 0.98 ± 3.20 | 1.00 ± 3.45 |
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.
| Sit-ups | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up | 2.67 ± 5.65 | 3.29 ± 5.25 | 2.43 ± 5.80 |
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.
| Pushups | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup | 2.37 ± 5.70 | 1.93 ± 5.40 | 2.27 ± 5.95 |
The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.
| Newton meters (Nm)/kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second | -4.10 ± 34.80 | -2.05 ± 31.55 | -1.91 ± 34.80 |
The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.
| Nm/kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second | -6.62 ± 28.95 | -0.59 ± 25.70 | 4.16 ± 28.35 |
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
| Nm/kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second | -0.64 ± 28.10 | 0.78 ± 25.50 | 2.55 ± 28.10 |
The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.
| Nm/kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second | 3.94 ± 16.25 | -3.74 ± 14.75 | -2.81 ± 16.65 |
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.
| Nm/kg | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second | 3.82 ± 12.85 | -3.00 ± 11.65 | -2.14 ± 13.15 |
Collected over Adverse events were collected from the on-study date until the completion of the intervention up to 24 weeks later.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Minimal Rewards | — | 0/25 (0%) | 2/25 (8%) |
| Group B: Immediate Incentives | — | 0/31 (0%) | 0/31 (0%) |
| Group C: Control | — | 0/26 (0%) | 0/26 (0%) |
| Event | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control |
|---|---|---|---|
| Abnormal ECGCardiac disorders | 2/25 | 0/31 | 0/26 |
| Age, Continuous(years) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Mean | 13.0 ± 1.2 | 12.8 ± 0.9 | 12.6 ± 1.2 | 12.8 ± 1.1 |
| Age, Customized(years) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Age at diagnosis | 3.0 ± 3.1 | 4.2 ± 3.0 | 3.6 ± 2.5 | 3.6 ± 2.9 |
| Time since diagnosis | 10.0 ± 3.0 | 8.6 ± 3.1 | 9.0 ± 2.7 | 9.2 ± 2.9 |
| Sex: Female, Male(Participants) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Female | 14 | 16 | 14 | 44 |
| Male | 11 | 15 | 12 | 38 |
| Race/Ethnicity, Customized(participants) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Non-White | 3 | 6 | 8 | 17 |
| White | 22 | 25 | 18 | 65 |
| Diagnosis(participants) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Leukemia | 5 | 7 | 7 | 19 |
| Central Nervous System Tumor | 7 | 7 | 4 | 18 |
| Lymphoma | 2 | 2 | 4 | 8 |
| Retinoblastoma | 6 | 5 | 2 | 13 |
| Other Solid Tumor | 5 | 10 | 9 | 24 |
| Daily Moderate to Vigorous Physical Activity (MVPA)(minutes) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Mean | 26.8 ± 15.7 | 28.0 ± 16.6 | 32.3 ± 22.6 | 29.0 ± 18.2 |
| Body mass index (BMI)(kg/m^2) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Mean | 25.0 ± 6.6 | 22.6 ± 6.3 | 22.8 ± 5.5 | 23.4 ± 6.1 |
| Resting heart rate (HR)(beats/minute) | Group A: Minimal Rewards | Group B: Immediate Incentives | Group C: Control | Total |
|---|---|---|---|---|
| Mean | 82.8 ± 11.2 | 80.4 ± 14.5 | 81.5 ± 14.9 | 81.5 ± 13.6 |
10 further baseline measures are reported on the registry.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Jude Children's Research Hospital