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Clinical Trials in Canada / NCT04089358
Active, not recruiting Phase 3

Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

NCT04089358 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2020-12-07
Last updated
2026-08-06

Condition(s) studied

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Educational InterventionFitBitGoal SettingHealth Promotion and EducationMedia InterventionTelephone-Based Intervention

Educational Intervention: Receive educational materials

FitBit: Wear a Fitbit

Goal Setting: Set goals

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)

Trial sites (116)

FacilityCityRegionStatus
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.

More Children's Oncology Group trials in Canada

Other trials for the same condition

Official registry record

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.

View NCT04089358 on ClinicalTrials.gov ↗ ← All trials in Canada