Health Promotion and Education: Receive text message about goal setting
Media Intervention: Follow Instagram group
Telephone-Based Intervention: Receive phone call about goal setting
Study summary
This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
Eligibility
Sex
ALL
Min age
15 Years
Max age
20 Years
Healthy volunteers
No
Inclusion Criteria:
* First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology \[ICD-O\] behavior code of "3") in first and continuous remission at the time of enrollment
* Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
* Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
* All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
* Patients must have a life expectancy of \> 1 year
* Self-report of \< 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
* Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
* Ambulatory and no known medical contraindications to increasing physical activity
* Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
* No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
* Able to read and write English
* Note: For patients \< 18 years, consenting parent/legal guardian does not have to be able to read and write English
* All patients and/or their parents or legal guardians must sign a written informed consent
* Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
* Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
* Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
* Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
Primary outcome measure(s)
Minutes of moderate-to-vigorous physical activity (MVPA) per day — 12 months Moderate-to-vigorous physical activity (MVPA) will be measured with a research-grade accelerometer which records minutes of MVPA over a 7 day period. This is used to calculate MVPA minutes at baseline and 12 months post-baseline. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. Will report the mean difference in average daily minutes of MVPA from baseline to 12 months, by arm, with corresponding 95% confidence intervals.
Trial sites (116)
Facility
City
Region
Status
USA Health Strada Patient Care Center
Mobile
Alabama
Banner Children's at Desert
Mesa
Arizona
Kaiser Permanente Downey Medical Center
Downey
California
City of Hope Comprehensive Cancer Center
Duarte
California
Miller Children's and Women's Hospital Long Beach
Long Beach
California
Children's Hospital Los Angeles
Los Angeles
California
Mattel Children's Hospital UCLA
Los Angeles
California
Valley Children's Hospital
Madera
California
UCSF Benioff Children's Hospital Oakland
Oakland
California
Kaiser Permanente-Oakland
Oakland
California
Children's Hospital of Orange County
Orange
California
University of California Davis Comprehensive Cancer Center
Sacramento
California
Santa Barbara Cottage Hospital
Santa Barbara
California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
California
Connecticut Children's Medical Center
Hartford
Connecticut
Yale University
New Haven
Connecticut
Alfred I duPont Hospital for Children
Wilmington
Delaware
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
Children's National Medical Center
Washington D.C.
District of Columbia
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
UF Health Cancer Institute - Gainesville
Gainesville
Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
Palms West Radiation Therapy
Loxahatchee Groves
Florida
Miami Cancer Institute
Miami
Florida
AdventHealth Orlando
Orlando
Florida
Arnold Palmer Hospital for Children
Orlando
Florida
Nemours Children's Hospital
Orlando
Florida
Sacred Heart Hospital
Pensacola
Florida
Johns Hopkins All Children's Hospital
St. Petersburg
Florida
Tampa General Hospital
Tampa
Florida
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
Augusta University Medical Center
Augusta
Georgia
Memorial Health University Medical Center
Savannah
Georgia
Saint Luke's Cancer Institute - Boise
Boise
Idaho
Lurie Children's Hospital-Chicago
Chicago
Illinois
University of Illinois
Chicago
Illinois
OSF Children's Hospital of Illinois
Peoria
Illinois
Southern Illinois University School of Medicine
Springfield
Illinois
Riley Hospital for Children
Indianapolis
Indiana
+ 76 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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