A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 236
- 主要终点
- Physiologic cost index (PCI)
研究概览
简要总结
This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
详细描述
PRIMARY OBJECTIVE:
I. To compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.
SECONDARY OBJECTIVES:
I. To evaluate the effect of a rewards-based, socially interactive web-based physical activity intervention on markers of cardiometabolic health among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction).
II. To evaluate the effect of a rewards-based, socially interactive, web-based physical activity intervention on physical activity, quality of life, fatigue, and school attendance among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission
- •Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 months at a Childrens Oncology Group (COG) institution
- •Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age
- •At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week
- •Patient and at least one parent/guardian are able to read and write English, Spanish, and/or French; at least 1 parent/guardian must be able to read and write English, Spanish, and/or French in order to assist the patient with using their physical activity tracking device account
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Patients with previous hematopoietic stem cell transplant (HSCT)
- •Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
- •Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test
- •Female patient who is postmenarcheal and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation
- •Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g. unresolved posterior fossa syndrome) are not eligible
研究组 & 干预措施
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Internet-Based Intervention (Other)
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Educational Intervention (Other)
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Medical Device Usage and Evaluation (Device)
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Quality-of-Life Assessment (Other)
Arm I (tracking device, limited version of device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.
干预措施: Questionnaire Administration (Other)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Educational Intervention (Other)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Internet-Based Intervention (Other)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Medical Device Usage and Evaluation (Device)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Quality-of-Life Assessment (Other)
Arm II (tracking device, interactive-reward based device)
Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Physiologic cost index (PCI)
时间窗: Up to 24 weeks (end of intervention)
Differences in PCI will be compared between groups at the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution.
Physiologic Cost Index (PCI)
时间窗: Baseline and 24 weeks
PCI is calculated in beats per meter from the average heart rate during the walking test minus the resting heart rate divided by meters walked per minute. Differences in PCI will be compared between groups at 24 weeks, the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution. Changes from baseline will be estimated as differences between model-based least squares means at specified time points (e.g., 24 weeks minus baseline) derived from the mixed model.
次要结局
- Change in inflammation(Baseline up to 48 weeks post intervention)
- Change in school attendance(Baseline up to 48 weeks post intervention)
- Change in markers of cardiometabolic health(Baseline up to 48 weeks post intervention)
- Change in quality of life(Baseline up to 48 weeks post intervention)
- Change in fatigue(Baseline up to 48 weeks post intervention)
- Markers of cardiometabolic health(Up to 48 weeks post intervention)
- Change in Markers of Cardiometabolic Health(Baseline up to 48 weeks post intervention)
- Change in Inflammation(Baseline up to 48 weeks post intervention)
- Change in Quality of Life(Baseline up to 48 weeks post intervention)
- Change in Fatigue(Baseline up to 48 weeks post intervention)
- Change in School Attendance(Baseline up to 48 weeks post intervention)
- Markers of Cardiometabolic Health(Up to 48 weeks post intervention)