- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223753
Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer
A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Recruiting
- CancerCare Manitoba
-
Contact:
- Site Public Contact
- Phone Number: 866-561-1026
- Email: ctu_web@cancercare.mb.ca
-
Principal Investigator:
- Ashley Chopek
-
-
Newfoundland and Labrador
-
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
- Active, not recruiting
- Janeway Child Health Centre
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Recruiting
- Kingston Health Sciences Centre
-
Contact:
- Site Public Contact
- Phone Number: 613-549-6666
- Email: cc-clinicaltrials@kgh.kari.net
-
Principal Investigator:
- Laura Wheaton
-
Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Children's Hospital of Eastern Ontario
-
Contact:
- Site Public Contact
- Phone Number: 613-737-7600
-
Principal Investigator:
- Donna L. Johnston
-
Toronto, Ontario, Canada, M5G 1X8
- Suspended
- Hospital for Sick Children
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- Children's Hospital of Alabama
-
Contact:
- Site Public Contact
- Phone Number: 205-638-9285
- Email: oncologyresearch@peds.uab.edu
-
Principal Investigator:
- Matthew A. Kutny
-
-
Arizona
-
Mesa, Arizona, United States, 85202
- Recruiting
- Banner Children's at Desert
-
Contact:
- Site Public Contact
- Phone Number: 480-412-3100
-
Principal Investigator:
- Joseph C. Torkildson
-
Phoenix, Arizona, United States, 85016
- Recruiting
- Phoenix Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 602-546-0920
-
Principal Investigator:
- Alexandra M. Walsh
-
Tucson, Arizona, United States, 85719
- Recruiting
- Banner University Medical Center - Tucson
-
Principal Investigator:
- Holly E. Pariury
-
Contact:
- Site Public Contact
- Email: UACC-IIT@uacc.arizona.edu
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202-3591
- Recruiting
- Arkansas Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 501-364-7373
-
Principal Investigator:
- David L. Becton
-
-
California
-
Downey, California, United States, 90242
- Recruiting
- Kaiser Permanente Downey Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 626-564-3455
-
Principal Investigator:
- Lisa A. Mueller
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Saro H. Armenian
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's and Women's Hospital Long Beach
-
Contact:
- Site Public Contact
- Phone Number: 562-933-5600
-
Principal Investigator:
- Jacqueline N. Casillas
-
Madera, California, United States, 93636
- Recruiting
- Valley Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 559-353-3000
- Email: Research@valleychildrens.org
-
Principal Investigator:
- Karen S. Fernandez
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Aarati V. Rao
-
Oakland, California, United States, 94609
- Recruiting
- UCSF Benioff Children's Hospital Oakland
-
Principal Investigator:
- Jennifer G. Michlitsch
-
Contact:
- Site Public Contact
- Phone Number: 510-428-3264
- Email: cogbchoak@ucsf.edu
-
Palo Alto, California, United States, 94304
- Recruiting
- Lucile Packard Children's Hospital Stanford University
-
Contact:
- Site Public Contact
- Phone Number: 800-694-0012
- Email: ccto-office@stanford.edu
-
Principal Investigator:
- Jay Michael S. Balagtas
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 916-734-3089
-
Principal Investigator:
- Marcio H. Malogolowkin
-
San Diego, California, United States, 92123
- Recruiting
- Rady Children's Hospital - San Diego
-
Contact:
- Site Public Contact
- Phone Number: 858-966-5934
-
Principal Investigator:
- William D. Roberts
-
Torrance, California, United States, 90502
- Active, not recruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Site Public Contact
- Phone Number: 303-764-5056
- Email: josh.b.gordon@nsmtp.kp.org
-
Principal Investigator:
- Kelly W. Maloney
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 860-545-9981
-
Principal Investigator:
- Michael S. Isakoff
-
New Haven, Connecticut, United States, 06520
- Active, not recruiting
- Yale University
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Alfred I duPont Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Recruiting
- Children's National Medical Center
-
Principal Investigator:
- Jeffrey S. Dome
-
Contact:
- Site Public Contact
- Phone Number: 202-476-2800
- Email: OncCRC_OnCall@childrensnational.org
-
Washington, District of Columbia, United States, 20007
- Recruiting
- MedStar Georgetown University Hospital
-
Contact:
- Site Public Contact
- Phone Number: 202-444-2223
-
Principal Investigator:
- Caileigh Pudela
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33316
- Recruiting
- Broward Health Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Hector M. Rodriguez-Cortes
-
Fort Myers, Florida, United States, 33908
- Recruiting
- Golisano Children's Hospital of Southwest Florida
-
Contact:
- Site Public Contact
- Phone Number: 239-343-5333
- Email: molly.arnstrom@leehealth.org
-
Principal Investigator:
- Emad K. Salman
-
Jacksonville, Florida, United States, 32207
- Recruiting
- Nemours Children's Clinic-Jacksonville
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
Loxahatchee Groves, Florida, United States, 33470
- Active, not recruiting
- Palms West Radiation Therapy
-
Orlando, Florida, United States, 32806
- Recruiting
- Arnold Palmer Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 321-841-5357
- Email: Jennifer.spinelli@orlandohealth.com
-
Principal Investigator:
- Amy A. Smith
-
Orlando, Florida, United States, 32827
- Recruiting
- Nemours Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 302-651-5572
- Email: Allison.bruce@nemours.org
-
Principal Investigator:
- Ramamoorthy Nagasubramanian
-
Tampa, Florida, United States, 33606
- Recruiting
- Tampa General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 813-844-7829
- Email: syapchanyk@tgh.org
-
Principal Investigator:
- Andrew J. Galligan
-
Tampa, Florida, United States, 33607
- Recruiting
- Saint Joseph's Hospital/Children's Hospital-Tampa
-
Contact:
- Site Public Contact
- Phone Number: 813-357-0849
- Email: jennifer.manns@baycare.org
-
Principal Investigator:
- Don E. Eslin
-
West Palm Beach, Florida, United States, 33407
- Recruiting
- Saint Mary's Hospital
-
Principal Investigator:
- Muaz A. Alrazzak
-
Contact:
- Site Public Contact
- Phone Number: 561-881-2815
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta - Egleston
-
Contact:
- Site Public Contact
- Phone Number: 404-785-2025
- Email: Leann.Schilling@choa.org
-
Principal Investigator:
- Sharon M. Castellino
-
Macon, Georgia, United States, 31201
- Recruiting
- Medical Center of Central Georgia
-
Principal Investigator:
- Sushmita Nair
-
Contact:
- Site Public Contact
- Phone Number: 478-633-2152
- Email: andrew.weatherall@atriumhealth.org
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96826
- Recruiting
- Kapiolani Medical Center for Women and Children
-
Contact:
- Site Public Contact
- Phone Number: 808-983-6090
-
Principal Investigator:
- Wade T. Kyono
-
-
Idaho
-
Boise, Idaho, United States, 83712
- Recruiting
- Saint Luke's Cancer Institute - Boise
-
Principal Investigator:
- Martha M. Pacheco
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Principal Investigator:
- Tara O. Henderson
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Site Public Contact
- Phone Number: 312-355-3046
-
Principal Investigator:
- Dipti S. Dighe
-
Oak Lawn, Illinois, United States, 60453
- Recruiting
- Advocate Children's Hospital-Oak Lawn
-
Contact:
- Site Public Contact
- Phone Number: 847-723-7570
-
Principal Investigator:
- Rebecca E. McFall
-
Park Ridge, Illinois, United States, 60068
- Recruiting
- Advocate Children's Hospital-Park Ridge
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Rebecca E. McFall
-
Peoria, Illinois, United States, 61637
- Recruiting
- Saint Jude Midwest Affiliate
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
-
Principal Investigator:
- Prerna Kumar
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Site Public Contact
- Phone Number: 800-248-1199
-
Principal Investigator:
- Sandeep Batra
-
Indianapolis, Indiana, United States, 46260
- Recruiting
- Ascension Saint Vincent Indianapolis Hospital
-
Contact:
- Site Public Contact
- Phone Number: 317-338-2194
- Email: research@stvincent.org
-
Principal Investigator:
- Bassem I. Razzouk
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-237-1225
-
Principal Investigator:
- David S. Dickens
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky/Markey Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 859-257-3379
-
Principal Investigator:
- James T. Badgett
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Norton Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 502-629-5500
- Email: CancerResource@nortonhealthcare.org
-
Principal Investigator:
- Ashok B. Raj
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70118
- Recruiting
- Children's Hospital New Orleans
-
Contact:
- Site Public Contact
- Email: CHResearch@lcmchealth.org
-
Principal Investigator:
- Lolie C. Yu
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center Jefferson
-
Contact:
- Site Public Contact
- Phone Number: 504-842-8084
- Email: Elisemarie.curry@ochsner.org
-
Principal Investigator:
- Craig Lotterman
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital of Baltimore
-
Contact:
- Site Public Contact
- Phone Number: 410-601-6120
- Email: pridgely@lifebridgehealth.org
-
Principal Investigator:
- Jason M. Fixler
-
Baltimore, Maryland, United States, 21201
- Active, not recruiting
- University of Maryland/Greenebaum Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Active, not recruiting
- Tufts Children's Hospital
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- C S Mott Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-865-1125
-
Principal Investigator:
- Rama Jasty
-
Detroit, Michigan, United States, 48201
- Active, not recruiting
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48201
- Recruiting
- Children's Hospital of Michigan
-
Principal Investigator:
- Alissa M. Martin
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota/Masonic Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 612-624-2620
-
Principal Investigator:
- Lucie M. Turcotte
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Site Public Contact
- Phone Number: 855-776-0015
-
Principal Investigator:
- Wendy Allen-Rhoades
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Columbia Regional
-
Contact:
- Site Public Contact
- Email: helpdesk@childrensoncologygroup.org
-
Principal Investigator:
- Barbara A. Gruner
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospitals and Clinics
-
Contact:
- Site Public Contact
- Phone Number: 816-302-6808
- Email: rryan@cmh.edu
-
Principal Investigator:
- Keith J. August
-
Saint Louis, Missouri, United States, 63141
- Recruiting
- Mercy Hospital Saint Louis
-
Contact:
- Site Public Contact
- Phone Number: 314-251-7066
-
Principal Investigator:
- Robin D. Hanson
-
Saint Louis, Missouri, United States, 63110
- Active, not recruiting
- Washington University School of Medicine
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Hospital and Medical Center of Omaha
-
Contact:
- Site Public Contact
- Phone Number: 402-955-3949
-
Principal Investigator:
- Jill C. Beck
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Jill C. Beck
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- Recruiting
- University Medical Center of Southern Nevada
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Las Vegas, Nevada, United States, 89109
- Recruiting
- Sunrise Hospital and Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Las Vegas, Nevada, United States, 89135
- Recruiting
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Las Vegas, Nevada, United States, 89144
- Recruiting
- Summerlin Hospital Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
Reno, Nevada, United States, 89502
- Recruiting
- Renown Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 702-384-0013
- Email: research@sncrf.org
-
Principal Investigator:
- Alan K. Ikeda
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 201-996-2879
-
Principal Investigator:
- Burton E. Appel
-
New Brunswick, New Jersey, United States, 08903
- Active, not recruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
Paterson, New Jersey, United States, 07503
- Recruiting
- Saint Joseph's Regional Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 973-754-2207
- Email: HallL@sjhmc.org
-
Principal Investigator:
- Alissa Kahn
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Active, not recruiting
- University of New Mexico Cancer Center
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 518-262-5513
-
Principal Investigator:
- Lauren R. Weintraub
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-767-9355
- Email: askroswell@roswellpark.org
-
Principal Investigator:
- Denise A. Rokitka
-
Valhalla, New York, United States, 10595
- Active, not recruiting
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Recruiting
- Mission Hospital
-
Contact:
- Site Public Contact
- Phone Number: 828-213-7055
- Email: NCDV.ResearchRegulatory@HCAHealthcare.com
-
Principal Investigator:
- Douglas J. Scothorn
-
Charlotte, North Carolina, United States, 28203
- Recruiting
- Carolinas Medical Center/Levine Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 800-804-9376
-
Principal Investigator:
- Joel A. Kaplan
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Novant Health Presbyterian Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 980-201-6360
- Email: kashah@novanthealth.org
-
Principal Investigator:
- Jessica A. Bell
-
Greenville, North Carolina, United States, 27834
- Recruiting
- East Carolina University
-
Contact:
- Site Public Contact
- Phone Number: 252-744-1015
- Email: eubankss@ecu.edu
-
Principal Investigator:
- Andrea R. Whitfield
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Recruiting
- Children's Hospital Medical Center of Akron
-
Contact:
- Site Public Contact
- Phone Number: 330-543-3193
-
Principal Investigator:
- Erin Wright
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Principal Investigator:
- Rabi Hanna
-
Columbus, Ohio, United States, 43205
- Active, not recruiting
- Nationwide Children's Hospital
-
Toledo, Ohio, United States, 43606
- Recruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 419-824-1842
- Email: PCIOncResearch@promedica.org
-
Principal Investigator:
- Jamie L. Dargart
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Rene Y. McNall-Knapp
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Recruiting
- Legacy Emanuel Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2560
-
Principal Investigator:
- Janice F. Olson
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Site Public Contact
- Phone Number: 503-494-1080
- Email: trials@ohsu.edu
-
Principal Investigator:
- Susan J. Lindemulder
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- Active, not recruiting
- Lehigh Valley Hospital-Cedar Crest
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Jagadeesh Ramdas
-
Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- Children's Hospital of Pittsburgh of UPMC
-
Contact:
- Site Public Contact
- Phone Number: 412-692-8570
- Email: jean.tersak@chp.edu
-
Principal Investigator:
- Jean M. Tersak
-
-
South Carolina
-
Columbia, South Carolina, United States, 29203
- Recruiting
- Prisma Health Richland Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-241-6251
-
Principal Investigator:
- Stuart L. Cramer
-
Greenville, South Carolina, United States, 29605
- Active, not recruiting
- BI-LO Charities Children's Cancer Center
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Recruiting
- T C Thompson Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 423-778-7289
-
Principal Investigator:
- Benjamin A. Mixon
-
Knoxville, Tennessee, United States, 37916
- Recruiting
- East Tennessee Childrens Hospital
-
Contact:
- Site Public Contact
- Phone Number: 865-541-8266
-
Principal Investigator:
- Susan E. Spiller
-
Memphis, Tennessee, United States, 38105
- Recruiting
- Saint Jude Children's Research Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
Principal Investigator:
- Kirsten K. Ness
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-811-8480
-
Principal Investigator:
- Adam J. Esbenshade
-
Nashville, Tennessee, United States, 37203
- Recruiting
- The Children's Hospital at TriStar Centennial
-
Contact:
- Site Public Contact
- Phone Number: 615-342-1919
-
Principal Investigator:
- Jennifer A. Domm
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Recruiting
- Texas Tech University Health Sciences Center-Amarillo
-
Principal Investigator:
- Smita Bhaskaran
-
Contact:
- Site Public Contact
- Phone Number: 806-354-5411
-
Austin, Texas, United States, 78723
- Recruiting
- Dell Children's Medical Center of Central Texas
-
Contact:
- Site Public Contact
- Phone Number: 512-628-1902
- Email: TXAUS-DL-SFCHemonc.research@ascension.org
-
Principal Investigator:
- Shannon M. Cohn
-
Corpus Christi, Texas, United States, 78411
- Recruiting
- Driscoll Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 361-694-5311
- Email: Crystal.DeLosSantos@dchstx.org
-
Principal Investigator:
- Nkechi I. Mba
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Naomi J. Winick
-
El Paso, Texas, United States, 79905
- Recruiting
- El Paso Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 915-298-5444
- Email: ranjan.bista@ttuhsc.edu
-
Principal Investigator:
- Benjamin Carcamo
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 713-798-1354
- Email: burton@bcm.edu
-
Principal Investigator:
- Maria M. Gramatges
-
Lubbock, Texas, United States, 79415
- Recruiting
- UMC Cancer Center / UMC Health System
-
Contact:
- Site Public Contact
- Phone Number: 806-775-8590
-
Principal Investigator:
- Erin K. Barr
-
McAllen, Texas, United States, 78503
- Recruiting
- Vannie Cook Children's Clinic
-
Contact:
- Site Public Contact
- Phone Number: 832-828-1727
- Email: jrhartl1@txch.org
-
Principal Investigator:
- Juan C. Bernini
-
San Antonio, Texas, United States, 78207
- Recruiting
- Children's Hospital of San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-704-2894
- Email: bridget.medina@christushealth.org
-
Principal Investigator:
- Timothy C. Griffin
-
San Antonio, Texas, United States, 78229
- Recruiting
- University of Texas Health Science Center at San Antonio
-
Contact:
- Site Public Contact
- Phone Number: 210-450-3800
- Email: phoresearchoffice@uthscsa.edu
-
Principal Investigator:
- Anne-Marie R. Langevin
-
San Antonio, Texas, United States, 78229
- Recruiting
- Methodist Children's Hospital of South Texas
-
Contact:
- Site Public Contact
- Phone Number: 210-575-6240
- Email: Vinod.GidvaniDiaz@hcahealthcare.com
-
Principal Investigator:
- Jose M. Esquilin
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Recruiting
- Children's Hospital of The King's Daughters
-
Contact:
- Site Public Contact
- Phone Number: 757-668-7243
- Email: CCBDCresearch@chkd.org
-
Principal Investigator:
- Eric J. Lowe
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Children's
-
Contact:
- Site Public Contact
- Phone Number: 540-266-6238
- Email: wpmccarty@carilionclinic.org
-
Principal Investigator:
- Erwood G. Edwards
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 866-987-2000
-
Principal Investigator:
- Sarah E. Leary
-
Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart Medical Center and Children's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-228-6618
- Email: HopeBeginsHere@providence.org
-
Principal Investigator:
- Judy L. Felgenhauer
-
Tacoma, Washington, United States, 98405
- Recruiting
- Mary Bridge Children's Hospital and Health Center
-
Contact:
- Site Public Contact
- Phone Number: 253-403-1461
- Email: research@multicare.org
-
Principal Investigator:
- Robert G. Irwin
-
-
West Virginia
-
Charleston, West Virginia, United States, 25304
- Active, not recruiting
- West Virginia University Charleston Division
-
Morgantown, West Virginia, United States, 26506
- Suspended
- West Virginia University Healthcare
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54301
- Recruiting
- Saint Vincent Hospital Cancer Center Green Bay
-
Contact:
- Site Public Contact
- Phone Number: 920-433-8889
- Email: ewd_research_admin@hshs.org
-
Principal Investigator:
- Catherine A. Long
-
Madison, Wisconsin, United States, 53792
- Active, not recruiting
- University of Wisconsin Carbone Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Receive educational handouts about to physical activity
Other Names:
Access limited version of device app/website
Access full version of interactive reward-based device app/website
Wear physical activity tracking device
|
Experimental: 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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Receive educational handouts about to physical activity
Other Names:
Access limited version of device app/website
Access full version of interactive reward-based device app/website
Wear physical activity tracking device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiologic cost index (PCI)
Time Frame: 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.
|
Up to 24 weeks (end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in markers of cardiometabolic health
Time Frame: Baseline up to 48 weeks post intervention
|
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
Time Frame: Baseline up to 48 weeks post intervention
|
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
Time Frame: Baseline up to 48 weeks post intervention
|
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
Time Frame: Baseline up to 48 weeks post intervention
|
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
Time Frame: Baseline up to 48 weeks post intervention
|
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
Time Frame: Up to 48 weeks post intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsten K Ness, Children's Oncology Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTE1631 (Other Identifier: CTEP)
- UG1CA189955 (U.S. NIH Grant/Contract)
- NCI-2017-01219 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-ALTE1631 (Other Identifier: DCP)
- R01CA193478 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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