Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

Last updated: April 16, 2025
Sponsor: Children's Oncology Group
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neoplasms

Precancerous Condition

Genitourinary Cancer

Treatment

Internet-Based Intervention

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Clinical Study ID

NCT03223753
ALTE1631
NCI-2017-01219
R01CA193478
ALTE1631
COG-ALTE1631
UG1CA189955
  • Ages 8-16
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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/orchemotherapy) within the past 12 months at a Childrens Oncology Group (COG)institution

  • Patients must have a performance status corresponding to Eastern CooperativeOncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years ofage

  • At the time of consent, patient or parent/guardian reports less than 420 minutes ofmoderate 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 writeEnglish, Spanish, and/or French in order to assist the patient with using theirphysical activity tracking device account

  • All patients and/or their parents or legal guardians must sign a written informedconsent

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion

Exclusion Criteria:

  • Patients with previous hematopoietic stem cell transplant (HSCT)

  • Patients with significant concurrent disease, illness, psychiatric disorder orsocial issue that would compromise patient safety or compliance with protocoltherapy, or interfere with consent, study participation, follow up, orinterpretation of study results

  • Female patients who are pregnant are not eligible; women of childbearing potentialrequire a negative pregnancy test

  • Female patient who is postmenarcheal and has not agreed to use an effectivecontraceptive method (including abstinence) for the duration of study participation

  • Patients with a cognitive, motor, visual or auditory impairment that preventscomputer use (e.g. unresolved posterior fossa syndrome) are not eligible

Study Design

Total Participants: 300
Treatment Group(s): 6
Primary Treatment: Internet-Based Intervention
Phase: 3
Study Start date:
November 29, 2017
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Janeway Child Health Centre

    Saint John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Children's Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Banner Children's at Desert

    Mesa, Arizona 85202
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Banner University Medical Center - Tucson

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591
    United States

    Site Not Available

  • Kaiser Permanente Downey Medical Center

    Downey, California 90242
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Site Not Available

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Kaiser Permanente-Oakland

    Oakland, California 94611
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Rady Children's Hospital - San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • UCSF Medical Center-Mission Bay

    San Francisco, California 94158
    United States

    Site Not Available

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Broward Health Medical Center

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Palms West Radiation Therapy

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Nemours Children's Hospital

    Orlando, Florida 32827
    United States

    Site Not Available

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Saint Mary's Hospital

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Saint Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Atrium Health Navicent

    Macon, Georgia 31201
    United States

    Site Not Available

  • Medical Center of Central Georgia

    Macon, Georgia 31201
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho 83712
    United States

    Site Not Available

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Saint Jude Midwest Affiliate

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Riley Hospital for Children

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Norton Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Children's Hospital New Orleans

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Tufts Children's Hospital

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • C S Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Columbia Regional

    Columbia, Missouri 65201
    United States

    Site Not Available

  • University of Missouri Children's Hospital

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Children's Hospital Medical Center of Akron

    Akron, Ohio 44308
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Legacy Emanuel Children's Hospital

    Portland, Oregon 97227
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Childrens Oncology Group

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Prisma Health Richland Hospital

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center-Amarillo

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Dell Children's Medical Center of Central Texas

    Austin, Texas 78723
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • El Paso Children's Hospital

    El Paso, Texas 79905
    United States

    Site Not Available

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • UMC Cancer Center / UMC Health System

    Lubbock, Texas 79415
    United States

    Site Not Available

  • Vannie Cook Children's Clinic

    McAllen, Texas 78503
    United States

    Site Not Available

  • Children's Hospital of San Antonio

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Carilion Children's

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington 99204
    United States

    Site Not Available

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington 98405
    United States

    Site Not Available

  • West Virginia University Charleston Division

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • West Virginia University Healthcare

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin 53792
    United States

    Site Not Available

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