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

StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Educational Intervention; Device: FitBit; Other: Goal Setting; Other: Health Promotion and Education; Other: Media Intervention; Behavioral: Telephone-Based Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

SECONDARY OBJECTIVES:

I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

OUTLINE: Participants are randomized to 1 of 2 groups.

INTERVENTION GROUP: Participants receive educational materials about physical activity.

INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit.

MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges.

CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • USA Health Strada Patient Care Center
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Banner Children's at Desert
  • California
    • Downey, California, United States, 90242
      • Kaiser Permanente Downey Medical Center
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Long Beach, California, United States, 90806
      • Miller Children's and Women's Hospital Long Beach
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Los Angeles, California, United States, 90095
      • Mattel Children's Hospital UCLA
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • Santa Barbara, California, United States, 93102
      • Santa Barbara Cottage Hospital
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I duPont Hospital for Children
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Fort Myers, Florida, United States, 33908
      • Golisano Children's Hospital of Southwest Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Cancer Institute - Gainesville
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic-Jacksonville
    • Loxahatchee Groves, Florida, United States, 33470
      • Palms West Radiation Therapy
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hospital
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital for Children
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Hospital
    • St. Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33607
      • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Idaho
    • Boise, Idaho, United States, 83712
      • Saint Luke's Cancer Institute - Boise
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital-Chicago
    • Peoria, Illinois, United States, 61637
      • Saint Jude Midwest Affiliate
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
    • Indianapolis, Indiana, United States, 46260
      • Ascension Saint Vincent Indianapolis Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Blank Children's Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital New Orleans
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Scarborough, Maine, United States, 04074
      • Maine Children's Cancer Program
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Bethesda, Maryland, United States, 20889-5600
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C S Mott Children's Hospital
    • East Lansing, Michigan, United States, 48823
      • Michigan State University
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health Children's
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota - Minneapolis
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota/Masonic Cancer Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital and Medical Center of Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital Medical Center
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital and Medical Center
    • Las Vegas, Nevada, United States, 89135
      • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center/Levine Cancer Institute
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Broadway Medical Center
  • Ohio
    • Akron, Ohio, United States, 44308
      • Children's Hospital Medical Center of Akron
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Children's Hospital
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Children's Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19134
      • Saint Christopher's Hospital for Children
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • BI-LO Charities Children's Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • East Tennessee Childrens Hospital
    • Memphis, Tennessee, United States, 38105
      • Saint Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37203
      • The Children's Hospital at TriStar Centennial
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Tech University Health Sciences Center-Amarillo
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Simmons Cancer Center-Dallas
    • El Paso, Texas, United States, 79905
      • El Paso Children's Hospital
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • McAllen, Texas, United States, 78503
      • Vannie Cook Children's Clinic
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78229
      • Methodist Children's Hospital of South Texas
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters
    • Richmond, Virginia, United States, 23298
      • VCU Massey Comprehensive Cancer Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center and Children's Hospital
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital Cancer Center Green Bay
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center - University Hospital
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group (educational materials, Fitbit); Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.	Other: Educational Intervention; Receive educational materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Device: FitBit; Wear a Fitbit
Experimental: Intervention group (educational materials, goal set, Fitbit); See outline	Other: Educational Intervention; Receive educational materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Device: FitBit; Wear a Fitbit; Other: Goal Setting; Set goals; Other: Health Promotion and Education; Receive text message about goal setting; Other: Media Intervention; Follow Instagram group; Behavioral: Telephone-Based Intervention; Receive phone call about goal setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes of moderate-to-vigorous physical activity (MVPA) per day	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary fitness	Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. Participants complete the 2-Minute Step Test at baseline and 12 months post-baseline. Steps are counted during the test. Will report the mean difference in steps from baseline to 12 months, by arm, with corresponding 95% confidence intervals.	12 months
Resting heart rate	Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor prior to the participant initiating the 2-Minute Step Test at baseline and 12 months. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Health-related quality of life (HRQOL) Global Functioning	HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Global Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Health-related quality of life (HRQOL) Physical Functioning	HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Physical Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Health-related quality of life (HRQOL) Social Functioning	HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Social Functioning score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Health-related quality of life (HRQOL) Fatigue	HRQOL will be measured at baseline and 12 months with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. The Fatigue score will be transformed to a scale from 0-100, in which higher scores indicate better HRQOL. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Total cholesterol	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Total cholesterol will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
High density lipoprotein (HDL)	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Low density lipoprotein (LDL)	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. LDL will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Triglycerides	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. Triglycerides will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Insulin (HOMA-IR)	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HOMA-IR will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
Hemoglobin A1c (HbA1c)	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. HbA1c will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months
High sensitivity C-reactive protein (CRP)	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast at baseline and 12 months. CRP will be obtained from the samples. Will report the mean difference, by arm, with corresponding 95% confidence intervals.	12 months

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nina S Kadan-Lottick, Children's Oncology Group

Publications and helpful links

General Publications

• Beight LJ, Mendoza JA, Leisenring WM, Collier W, Olsen ME, Ross WL, Santiago-Rivera Y, Bryant S, Rotatori J, Ness KK, Hurtado-de-Mendoza A, Baker KS, Chow EJ, Kadan-Lottick NS. Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group. Contemp Clin Trials. 2024 Oct;145:107645. doi: 10.1016/j.cct.2024.107645. Epub 2024 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Organization and Administration; Health Services Administration; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Health Education; Methods; Early Intervention, Educational; Educational Status; Health Promotion; Organizational Objectives
• Other Study ID Numbers: ALTE2031 (Other Identifier: CTEP); UG1CA189955 (U.S. NIH Grant/Contract); NCI-2020-01916 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-ALTE2031 (Other Identifier: DCP); U01CA246665 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No