CancerNCT01778127
A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
A study testing Activity Monitor, Interactive Website and Educational Materials in people with Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Cancer
- What is being tested?
- Activity Monitor, Interactive Website and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
- Pregnant female
- Inability to read and write English
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Activity Monitor, Interactive Website, Educational Materials
- Keywords
- Cancer Survivor, Physical Activity, Health Outcomes, Rewards-Based Intervention, Cardiovascular Health, Musculoskeletal Health, Exercise
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity MonitorBehavioural
Also called Tri-Axial Accelerometer, Zamzee
Measurement of physical activity.
Interactive WebsiteBehavioural
Also called Zamzee 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 MaterialsBehavioural
Also called Educational Brochure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Activity Monitor; Behavioral: Interactive Website; Behavioral: Educational Materials |
| 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. Receives: Behavioral: Activity Monitor; Behavioral: Interactive Website; Behavioral: Educational Materials |
| 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. Receives: Behavioral: Activity Monitor; Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (11)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten K. Ness, PT, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778127
- Sponsor's protocol ID
- ZAMZEE
- Other IDs
- NCI-2013-00384
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2013
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT01778127
- Acronym / sponsor ID
- ZAMZEE
- Conditions
- Cancer
- Keywords
- Cancer Survivor, Physical Activity, Health Outcomes, Rewards-Based Intervention, Cardiovascular Health, Musculoskeletal Health, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 21 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Minimal Rewards | Experimental | Behavioral: Activity Monitor, Behavioral: Interactive Website, Behavioral: Educational MaterialsParticipants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels. |
| Group B: Immediate Incentives | Experimental | Behavioral: Activity Monitor, Behavioral: Interactive Website, Behavioral: Educational MaterialsParticipants 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 | Behavioral: Activity Monitor, Behavioral: Educational MaterialsParticipants 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
- Pregnant female
- Inability to read and write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity MonitorAlso: Tri-Axial Accelerometer, ZamzeeMeasurement of physical activity. | Behavioural | Group A: Minimal Rewards, Group B: Immediate Incentives, Group C: Control |
| Interactive WebsiteAlso: Zamzee WebsiteZamzee 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. | Behavioural | Group A: Minimal Rewards, Group B: Immediate Incentives |
| Educational MaterialsAlso: Educational BrochureAll 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. | Behavioural | Group A: Minimal Rewards, Group B: Immediate Incentives, Group C: Control |
Primary outcome
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
Time frame: Baseline, Week 24
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.
11 secondary outcomes
Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks
Time frame: Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach
Time frame: Baseline and 24 weeks
Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second
Time frame: Baseline and 24 weeks
Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten K. Ness, PT, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Monitor, Interactive Website and Educational Materials in people with Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.