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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04089358
• Other study ID #: ALTE2031
• Secondary ID: NCI-2020-01916AL
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 7, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 384
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Educational Intervention
Receive educational materials

Device:
• FitBit
Wear a Fitbit

Other:
• Goal Setting
Set goals
• Health Promotion and Education
Receive text message about goal setting
• Media Intervention
Follow Instagram group

Behavioral:
• Telephone-Based Intervention
Receive phone call about goal setting

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas
United States	C S Mott Children's Hospital	Ann Arbor	Michigan
United States	Augusta University Medical Center	Augusta	Georgia
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Saint Luke's Cancer Institute - Boise	Boise	Idaho
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	Lurie Children's Hospital-Chicago	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Blank Children's Hospital	Des Moines	Iowa
United States	Kaiser Permanente Downey Medical Center	Downey	California
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Michigan State University Clinical Center	East Lansing	Michigan
United States	El Paso Children's Hospital	El Paso	Texas
United States	Sanford Broadway Medical Center	Fargo	North Dakota
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	University of Florida Health Science Center - Gainesville	Gainesville	Florida
United States	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	BI-LO Charities Children's Cancer Center	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Penn State Children's Hospital	Hershey	Pennsylvania
United States	Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida
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	Ascension Saint Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	East Tennessee Childrens Hospital	Knoxville	Tennessee
United States	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada
United States	Summerlin Hospital Medical Center	Las Vegas	Nevada
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center	Lebanon	New Hampshire
United States	Miller Children's and Women's Hospital Long Beach	Long Beach	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Mattel Children's Hospital UCLA	Los Angeles	California
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Palms West Radiation Therapy	Loxahatchee Groves	Florida
United States	Valley Children's Hospital	Madera	California
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Vannie Cook Children's Clinic	McAllen	Texas
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	Banner Children's at Desert	Mesa	Arizona
United States	Miami Cancer Institute	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	NYU Winthrop Hospital	Mineola	New York
United States	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	USA Health Strada Patient Care Center	Mobile	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	The Children's Hospital at TriStar Centennial	Nashville	Tennessee
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	Kaiser Permanente-Oakland	Oakland	California
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's Hospital and Medical Center of Omaha	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	Nemours Children's Hospital	Orlando	Florida
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Saint Jude Midwest Affiliate	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Saint Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Legacy Emanuel Children's Hospital	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Renown Regional Medical Center	Reno	Nevada
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Beaumont Children's Hospital-Royal Oak	Royal Oak	Michigan
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Seattle Children's Hospital	Seattle	Washington
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Children's National Medical Center	Washington	District of Columbia
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI), Yale University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation	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.	12 months
Secondary	Cardiopulmonary fitness	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.	12 months
Secondary	Body mass index (BMI)	Participants will be measured for height and weight without shoes and wearing light clothes using a stadiometer or measuring tape and scale, respectively. 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.	12 months
Secondary	Resting heart rate	Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor after the patient has been sitting upright with both feet on the floor for five minutes.	12 months
Secondary	Health-related quality of life (HRQOL)	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.	12 months
Secondary	Total cholesterol	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.	12 months
Secondary	High density lipoprotein (HDL)	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).	12 months
Secondary	Low density lipoprotein (LDL)	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).	12 months
Secondary	Triglycerides	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.	12 months
Secondary	Glucose	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.	12 months
Secondary	Insulin	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.	12 months
Secondary	Hemoglobin A1c (HbA1c)	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).	12 months
Secondary	High sensitivity C-reactive protein (CRP)	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).	12 months