ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT03223753 के लिए इन सीटू कार्सिनोमा, रक्तजनक और लसीका प्रणाली का नवोप्लाज्म, घातक ठोस नवोप्लाज्म वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT03223753 का मुख्य उद्देश्य रोकथाम का अध्ययन करना है। यह चिकित्सकीय अध्ययन इन सीटू कार्सिनोमा, रक्तजनक और लसीका प्रणाली का नवोप्लाज्म, घातक ठोस नवोप्लाज्म से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 29 नवंबर 2017 को हुई थी, और इसमें कुल 300 प्रतिभागियों के नामांकन की योजना है। Children's Oncology Group इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 मार्च 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 18 अप्रैल 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
विस्तृत विवरण
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.
आधिकारिक शीर्षक
A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
चिकित्सीय स्थितियाँ
इन सीटू कार्सिनोमारक्तजनक और लसीका प्रणाली का नवोप्लाज्मघातक ठोस नवोप्लाज्मप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- ALTE1631
- NCI-2017-01219 (रजिस्ट्री पहचानकर्ता) (CTRP (Clinical Trial Reporting Program))
- ALTE1631 (अन्य पहचानकर्ता) (Children's Oncology Group)
- COG-ALTE1631 (अन्य पहचानकर्ता) (DCP)
- ALTE1631 (अन्य पहचानकर्ता) (CTEP)
- R01CA193478 (यू.एस. एन.आई.एच. अनुदान/अनुबंध)
- UG1CA189955 (यू.एस. एन.आई.एच. अनुदान/अनुबंध)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2017-11-29
अंतिम अद्यतन प्रकाशित
2025-04-18
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-03-31
नामांकन (अनुमानित)
300
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
सक्रिय, भर्ती नहीं
प्राथमिक उद्देश्य
निवारण (रोकथाम)
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
सक्रिय तुलना समूहArm 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. | शैक्षिक हस्तक्षेप Receive educational handouts about to physical activity इंटरनेट-आधारित हस्तक्षेप Access limited version of device app/website प्रयोगशाला बायोमार्कर विश्लेषण Correlative studies चिकित्सकीय उपकरण का उपयोग और मूल्यांकन Wear physical activity tracking device जीवन की गुणवत्ता का मूल्यांकन Ancillary studies प्रश्नावली प्रशासन Ancillary studies |
प्रयोगात्मकArm 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. | शैक्षिक हस्तक्षेप Receive educational handouts about to physical activity इंटरनेट-आधारित हस्तक्षेप Access full version of interactive reward-based device app/website प्रयोगशाला बायोमार्कर विश्लेषण Correlative studies चिकित्सकीय उपकरण का उपयोग और मूल्यांकन Wear physical activity tracking device जीवन की गुणवत्ता का मूल्यांकन Ancillary studies प्रश्नावली प्रशासन Ancillary studies |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
8 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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 Groupराष्ट्रीय कैंसर संस्थान, अमेरिका3030 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिएकोई संपर्क डेटा नहीं।
118 2 देशों में अध्ययन स्थल
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