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临床试验 NCT03223753 针对原位癌，造血和淋巴系统肿瘤，恶性实体肿瘤目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer
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临床试验NCT03223753旨在研究预防，主要针对原位癌，造血和淋巴系统肿瘤，恶性实体肿瘤。这是一项III期 (第三期) 干预性研究试验，目前试验状态为进行中但不再招募。试验始于2017年11月29日，计划招募300名患者。该研究由Children's Oncology Group主导，预计于2026年3月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年4月18日。
简要概括
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).
III. To determine if the effect of a rewards-based, socially interactive, web-based physical activity intervention on markers of cardiometabolic health is mediated by changes in fitness among children and adolescents following treatment for cancer (compared to the same web-based physical activity intervention without social interaction).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a 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 the app/website to get basic information related to their physical activity. Patients will not be told of the details of earning of monetary incentives. Their activity will be monitored during the 6 month intervention period and will receive all earned gift cards or prizes after the intervention period ends. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives.
ARM II: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a 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 randomized to this study arm. Patients will receive additional details about how to earn gift cards or prizes for engaging in the intervention and will be rewarded for all earned incentives throughout the 6 month intervention period. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives.
After completion of study, patients are followed up at 24 and 48 weeks.
官方标题
A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
疾病
原位癌造血和淋巴系统肿瘤恶性实体肿瘤出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- ALTE1631
- NCI-2017-01219 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- ALTE1631 (其他标识符) (Children's Oncology Group)
- COG-ALTE1631 (其他标识符) (DCP)
- ALTE1631 (其他标识符) (CTEP)
- R01CA193478 (美国 NIH 拨款/合同)
- UG1CA189955 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2017-11-29
最近更新发布
2025-04-18
预计完成日期
2026-03-31
计划入组人数
300
研究类型
干预性研究
试验分期 (阶段)
III期 (第三期)
试验状态
进行中但不再招募
主要目的
预防
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照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. | 教育干预 Receive educational handouts about to physical activity 基于互联网的干预 Access limited version of device app/website 实验室生物标志物分析 Correlative studies 医疗设备使用和评估 Wear physical activity tracking device 生活质量评估 Ancillary studies 问卷管理 Ancillary studies |
实验性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. | 教育干预 Receive educational handouts about to physical activity 基于互联网的干预 Access full version of interactive reward-based device app/website 实验室生物标志物分析 Correlative studies 医疗设备使用和评估 Wear physical activity tracking device 生活质量评估 Ancillary studies 问卷管理 Ancillary studies |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Physiologic cost index (PCI) | 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. | Up to 24 weeks (end of intervention) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in markers of cardiometabolic health | Markers of Cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. Differences in these markers between randomized groups and the effects of group assignment on changes over time will be evaluated. | Baseline up to 48 weeks post intervention |
Change in inflammation | Markers of an Inflammatory state include High sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor alpha. Differences in these markers between groups and the effects of group assignment on changes over time will be evaluated. | Baseline up to 48 weeks post intervention |
Change in quality of life | Will be assessed using Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scale. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. Scores range from 0-100, higher is better. There are four scales (Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning). Emotional, Social and School Functioning can be combined to create a psychosocial summary (summed and divided by total number of items). Differences between groups and the effects of group assignment on changes over time will be evaluated. | Baseline up to 48 weeks post intervention |
Change in fatigue | Will be assessed using Pediatric Quality of Life Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. It has three dimensions, general fatigue, sleep/rest fatigue and cognitive fatigue. Scores range from 0-100 and items are summed and divided by the total to get the mean. Differences between groups and the effects of group assignment on changes over time will be evaluated. | Baseline up to 48 weeks post intervention |
Change in school attendance | Will be assessed using parent report. Differences between groups and the effects of group assignment on changes over time will be evaluated. | Baseline up to 48 weeks post intervention |
Markers of cardiometabolic health | Markers of cardiometabolic health include blood pressure, body mass index, waist to height ration, fasting insulin, glucose, and lipid levels. It will be determined if the effect of an interactive web-based physical activity intervention on markers of cardiometabolic health is mediated by changes in fitness among children and adolescents following treatment for acute lymphoblastic leukemia. A causal inference approach will evaluate whether group assignment results in an improved outcome in the presence of a lower PCI. This requires decomposing the averaged total effect into indirect and direct effects of group assignment of on the cardiometabolic outcomes. A principal stratification method will be used that classifies participants into strata based on their performance on the PCI (mediator variable) for each group of the randomized intervention. Mediation analyses would then be based on intent-to-treat effects of group assignment on cardiometabolic health outcome within each strata. | Up to 48 weeks post intervention |
资格标准
适龄参与研究
儿童
最低年龄要求
8 Years
适龄性别
全部
- 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
- 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
Children's Oncology Group国家癌症研究所3028 个活跃的临床试验可供探索没有联系数据。
118 位于 2 个国家/地区的研究中心
Alabama
Children's Hospital of Alabama, Birmingham, Alabama, 35233, United States
Arizona
Banner Children's at Desert, Mesa, Arizona, 85202, United States
Phoenix Childrens Hospital, Phoenix, Arizona, 85016, United States
Banner University Medical Center - Tucson, Tucson, Arizona, 85719, United States
Arkansas
Arkansas Children's Hospital, Little Rock, Arkansas, 72202-3591, United States
California
Kaiser Permanente Downey Medical Center, Downey, California, 90242, United States
City of Hope Comprehensive Cancer Center, Duarte, California, 91010, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, 90806, United States
Valley Children's Hospital, Madera, California, 93636, United States
UCSF Benioff Children's Hospital Oakland, Oakland, California, 94609, United States
Kaiser Permanente-Oakland, Oakland, California, 94611, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States
Rady Children's Hospital - San Diego, San Diego, California, 92123, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, 90502, United States
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
Connecticut
Connecticut Children's Medical Center, Hartford, Connecticut, 06106, United States
Yale University, New Haven, Connecticut, 06520, United States
Delaware
Alfred I duPont Hospital for Children, Wilmington, Delaware, 19803, United States
District of Columbia
MedStar Georgetown University Hospital, Washington D.C., District of Columbia, 20007, United States
Children's National Medical Center, Washington D.C., District of Columbia, 20010, United States
Florida
Broward Health Medical Center, Fort Lauderdale, Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, 32207, United States
Palms West Radiation Therapy, Loxahatchee Groves, Florida, 33470, United States
Arnold Palmer Hospital for Children, Orlando, Florida, 32806, United States
Nemours Children's Hospital, Orlando, Florida, 32827, United States
Tampa General Hospital, Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, 33607, United States
Saint Mary's Medical Center, West Palm Beach, Florida, 33407, United States
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, 30329, United States
Atrium Health Navicent, Macon, Georgia, 31201, United States
Hawaii
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States
Idaho
Saint Luke's Cancer Institute - Boise, Boise, Idaho, 83712, United States
Illinois
University of Illinois, Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States
Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois, 60068, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States
Indiana
Riley Hospital for Children, Indianapolis, Indiana, 46202, United States
Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States
Iowa
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States
Kentucky
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States
Norton Children's Hospital, Louisville, Kentucky, 40202, United States
Louisiana
Children's Hospital New Orleans, New Orleans, Louisiana, 70118, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121, United States
Maryland
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States
Massachusetts
Tufts Children's Hospital, Boston, Massachusetts, 02111, United States
Michigan
C S Mott Children's Hospital, Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States
Minnesota
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Missouri
University of Missouri Children's Hospital, Columbia, Missouri, 65212, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, 64108, United States
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis, St Louis, Missouri, 63141, United States
Nebraska
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States
Nevada
University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center, Las Vegas, Nevada, 89144, United States
Renown Regional Medical Center, Reno, Nevada, 89502, United States
New Jersey
Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, 08903, United States
Saint Joseph's Regional Medical Center, Paterson, New Jersey, 07503, United States
New Mexico
University of New Mexico Cancer Center, Albuquerque, New Mexico, 87106, United States
New York
Albany Medical Center, Albany, New York, 12208, United States
Roswell Park Cancer Institute, Buffalo, New York, 14263, United States
New York Medical College, Valhalla, New York, 10595, United States
North Carolina
Mission Hospital, Asheville, North Carolina, 28801, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, 28204, United States
East Carolina University, Greenville, North Carolina, 27834, United States
Ohio
Children's Hospital Medical Center of Akron, Akron, Ohio, 44308, United States
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital, Columbus, Ohio, 43205, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, 43606, United States
Oklahoma
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States
Oregon
Legacy Emanuel Children's Hospital, Portland, Oregon, 97227, United States
Oregon Health and Science University, Portland, Oregon, 97239, United States
Pennsylvania
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center, Danville, Pennsylvania, 17822, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15224, United States
South Carolina
Prisma Health Richland Hospital, Columbia, South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, 29605, United States
Tennessee
T C Thompson Children's Hospital, Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, 37916, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States
The Children's Hospital at TriStar Centennial, Nashville, Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 37232, United States
Texas
Texas Tech University Health Sciences Center-Amarillo, Amarillo, Texas, 79106, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, 78723, United States
Driscoll Children's Hospital, Corpus Christi, Texas, 78411, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, 75390, United States
El Paso Children's Hospital, El Paso, Texas, 79905, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, 77030, United States
UMC Cancer Center / UMC Health System, Lubbock, Texas, 79415, United States
Vannie Cook Children's Clinic, McAllen, Texas, 78503, United States
Children's Hospital of San Antonio, San Antonio, Texas, 78207, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
Virginia
Children's Hospital of The King's Daughters, Norfolk, Virginia, 23507, United States
Carilion Children's, Roanoke, Virginia, 24014, United States
Washington
Seattle Children's Hospital, Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, 98405, United States
West Virginia
West Virginia University Charleston Division, Charleston, West Virginia, 25304, United States
West Virginia University Healthcare, Morgantown, West Virginia, 26506, United States
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, 53792, United States
Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada
Newfoundland and Labrador
Janeway Child Health Centre, St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Ontario
Kingston Health Sciences Centre, Kingston, Ontario, K7L 2V7, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada