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

Phase 3

Active, not recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Educational Intervention; Device: FitBit; Other: Goal Setting; Other: Health Promotion and Education; Other: Media Intervention; Behavioral: Telephone-Based Intervention

• Registration Number: NCT04089358
• Lead Sponsor: Children's Oncology Group

Brief 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.

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 Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2020-12-07
• Status Verified: 2024-05
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 384

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (educational materials, goal set, Fitbit)	FitBit	See outline
Intervention group (educational materials, goal set, Fitbit)	Telephone-Based Intervention	See outline
Intervention group (educational materials, goal set, Fitbit)	Educational Intervention	See outline
Intervention group (educational materials, goal set, Fitbit)	Health Promotion and Education	See outline
Intervention group (educational materials, goal set, Fitbit)	Media Intervention	See outline
Control Group (educational materials, Fitbit)	Educational Intervention	Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
Control Group (educational materials, Fitbit)	FitBit	Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
Intervention group (educational materials, goal set, Fitbit)	Goal Setting	See outline

Primary Outcome Measures

Name	Time	Method
Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation	12 months	Moderate-to-vigorous physical activity (MVPA) will be tracked using a wearable activity monitor (research-grade accelerometer) that counts how often (how many times) someone performs MVPA over a 7 day period. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day.

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: total cholesterol.
Body mass index (BMI)	12 months	Self-reported height and weight will be collected from the participants prior to the participant initiating the 2-Minuite Step Test. BMI will be calculated as weight (kg) divided by height squared (m2). BMI will be examined as a potential covariate for the analysis of fitness as measured by the 2-Minute Step Test.
Triglycerides	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: triglycerides.
Resting heart rate	12 months	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.
Health-related quality of life (HRQOL)	12 months	HRQOL will be measured with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales (global functioning, physical functioning, and social functioning scales, specifically) and the 18-item PedsQL 4.0 Multidimensional Fatigue Scale, which encompasses three subscales: (1) general fatigue (6 items), (2) sleep/rest fatigue (6 items), and (3) cognitive fatigue (6 items).115-118 Questions refer to how much of a problem each item was during the past month. Items are reverse-scored and transformed to a scale from 0-100, in which higher scores indicate better HRQOL.
Low density lipoprotein (LDL)	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: low density lipoprotein (LDL).
Hemoglobin A1c (HbA1c)	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: hemoglobin A1c (HbA1c).
Cardiopulmonary fitness	12 months	Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. During the 2-Minute Step Test, participants are asked to march in place as quickly as possible for 2 minutes. This test requires a stopwatch and a counter. Stopping, starting, and resting during the test are allowed as needed. Steps are counted.
Glucose	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: glucose.
High sensitivity C-reactive protein (CRP)	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: high sensitivity C-reactive protein (CRP).
High density lipoprotein (HDL)	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: high density lipoprotein (HDL).
Insulin (HOMA-IR)	12 months	A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: insulin.

Trial Locations

Locations (116)

Banner Children's at Desert; 🇺🇸 Mesa, Arizona, United States

Kaiser Permanente Downey Medical Center; 🇺🇸 Downey, California, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University Medical Center of Southern Nevada; 🇺🇸 Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation; 🇺🇸 Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center; 🇺🇸 Las Vegas, Nevada, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

University of Minnesota/Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Blank Children's Hospital; 🇺🇸 Des Moines, Iowa, United States

Sanford Broadway Medical Center; 🇺🇸 Fargo, North Dakota, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

The Children's Hospital at TriStar Centennial; 🇺🇸 Nashville, Tennessee, United States

Legacy Emanuel Children's Hospital; 🇺🇸 Portland, Oregon, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Saint Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Sacred Heart Hospital; 🇺🇸 Pensacola, Florida, United States

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa; 🇺🇸 Tampa, Florida, United States

Saint Luke's Cancer Institute - Boise; 🇺🇸 Boise, Idaho, United States

USA Health Strada Patient Care Center; 🇺🇸 Mobile, Alabama, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Miller Children's and Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Mattel Children's Hospital UCLA; 🇺🇸 Los Angeles, California, United States

Valley Children's Hospital; 🇺🇸 Madera, California, United States

Kaiser Permanente-Oakland; 🇺🇸 Oakland, California, United States

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

Golisano Children's Hospital of Southwest Florida; 🇺🇸 Fort Myers, Florida, United States

Nemours Children's Clinic-Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Palms West Radiation Therapy; 🇺🇸 Loxahatchee Groves, Florida, United States

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States

Lurie Children's Hospital-Chicago; 🇺🇸 Chicago, Illinois, United States

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States

Saint Jude Midwest Affiliate; 🇺🇸 Peoria, Illinois, United States

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States

Ascension Saint Vincent Indianapolis Hospital; 🇺🇸 Indianapolis, Indiana, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Michigan State University Clinical Center; 🇺🇸 East Lansing, Michigan, United States

Bronson Methodist Hospital; 🇺🇸 Kalamazoo, Michigan, United States

Corewell Health Children's; 🇺🇸 Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

Mercy Hospital Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

NYU Langone Hospital - Long Island; 🇺🇸 Mineola, New York, United States

State University of New York Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Carolinas Medical Center/Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

Children's Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital; 🇺🇸 Toledo, Ohio, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn State Children's Hospital; 🇺🇸 Hershey, Pennsylvania, United States

Saint Christopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo; 🇺🇸 Amarillo, Texas, United States

El Paso Children's Hospital; 🇺🇸 El Paso, Texas, United States

Driscoll Children's Hospital; 🇺🇸 Corpus Christi, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center; 🇺🇸 Houston, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Methodist Children's Hospital of South Texas; 🇺🇸 San Antonio, Texas, United States

Vannie Cook Children's Clinic; 🇺🇸 McAllen, Texas, United States

Children's Hospital of The King's Daughters; 🇺🇸 Norfolk, Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay; 🇺🇸 Green Bay, Wisconsin, United States

Providence Sacred Heart Medical Center and Children's Hospital; 🇺🇸 Spokane, Washington, United States

Marshfield Medical Center-Marshfield; 🇺🇸 Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Norton Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Arnold Palmer Hospital for Children; 🇺🇸 Orlando, Florida, United States

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States

Nemours Children's Hospital; 🇺🇸 Orlando, Florida, United States

C S Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Alfred I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

UCSF Benioff Children's Hospital Oakland; 🇺🇸 Oakland, California, United States

Children's Hospital and Medical Center of Omaha; 🇺🇸 Omaha, Nebraska, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Maine Children's Cancer Program; 🇺🇸 Scarborough, Maine, United States

Summerlin Hospital Medical Center; 🇺🇸 Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

East Tennessee Childrens Hospital; 🇺🇸 Knoxville, Tennessee, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States

BI-LO Charities Children's Cancer Center; 🇺🇸 Greenville, South Carolina, United States

Dell Children's Medical Center of Central Texas; 🇺🇸 Austin, Texas, United States

Children's Hospital New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson; 🇺🇸 New Orleans, Louisiana, United States

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

University of Florida Health Science Center - Gainesville; 🇺🇸 Gainesville, Florida, United States

University of Wisconsin Carbone Cancer Center - University Hospital; 🇺🇸 Madison, Wisconsin, United States

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States