A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study
NCT ID: NCT06410209
Last Updated: 2025-10-24
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2024-10-15
2027-09-15
Brief Summary
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Detailed Description
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I. Use an iterative approach to develop a culturally-tailored multilevel remote-based physical activity (PA) intervention among a total of 20 Latinx adolescent and young adult survivors of childhood cancer (AYA survivors), 8-12 whose preferred language is English and 8-12 whose preferred language is Spanish, using the StepByStep intervention as a starting point. (Stage 1) II. Conduct a randomized controlled trial (RCT) to test the potential efficacy of the culturally-tailored remote-based PA intervention (versus \[vs.\] Fitbit only) with respect to the primary outcome of moderate to vigorous physical activity (MVPA) measured with a research grade accelerometer over 12 weeks among a separate group of 170 Latinx AYA survivors whose preferred language is Spanish or English (n=85 per randomization arm) and who do not meet PA guidelines at baseline. The control group will receive a Fitbit only. (Stage 2)
SECONDARY OBJECTIVES:
I. Among the patients enrolled to the RCT component of the study, evaluate the potential efficacy of randomization to the intervention relative to control arm with respect to decreasing sedentary time as assessed by a research accelerometer.
II. Evaluate potential efficacy of randomization to the active intervention arm with respect to improvement in reported health-related quality of life.
EXPLORATORY OBJECTIVES:
I. Evaluate potential efficacy of randomization to the active intervention arm with respect to physiological measurements predictive of cardiometabolic health.
II. Determine the acceptability of and guidance on improving the intervention phases in preparation for a fully powered, long term RCT by conducting two rounds of post-trial qualitative interviews among selected consenting participants, n=30 for the intensive intervention phase and n=30 for the maintenance intervention phase. Preferences and barriers for an additional diet and nutrition component will also be explored.
OUTLINE:
STAGE 1: Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months.
STAGE 2: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION):
INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, and receive badges for 12 weeks.
MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks.
GROUP II (CONTROL): Patients wear a Fitbit physical activity tracker daily for 12 weeks.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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Stage 1 (Fitbit, interview)
Patients wear a Fitbit physical activity tracker daily, set physical activity goals, receive text messages, and view private social media peer support group content over 7-10 days once every 3 months. Patients also wear a research grade activity measuring device over 1-3 days and participate in a one-on-one interview once every 3 months for 9 months.
Goal Setting
Set physical activity goals
Interview
Participate in a one-on-one interview
Media Intervention
View private social media peer support group content
Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Medical Device Usage and Evaluation
Wear a research grade activity measuring device
Questionnaire Administration
Ancillary studies
Text Message-Based Navigation Intervention
Receive text messages
Stage 2, Group I (Fitbit, goal setting, peer support)
INTENSIVE PHASE: Patients wear a Fitbit physical activity tracker daily and receive weekly reminders to wear the Fitbit for 12 weeks. Patients attend weekly goal setting sessions, receive individualized physical activity goals, view and post private social media peer support group content 2-3 times weekly, and receive badges for 12 weeks.
MAINTENANCE PHASE: Patients wear a Fitbit physical activity tracker daily and set their own physical activity goals weekly for 4 weeks. Patients also receive access to the social media account and post content for 4 weeks.
Goal Setting
Set physical activity goals
Interview
Ancillary studies
Media Intervention
View private social media peer support group content
Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Questionnaire Administration
Ancillary studies
Reward
Receive badges
Text Message-Based Navigation Intervention
Receive reminders
Stage 2, Group II (Fitbit)
Patients wear a Fitbit physical activity tracker daily for 12 weeks.
Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Questionnaire Administration
Ancillary studies
Interventions
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Goal Setting
Set physical activity goals
Interview
Participate in a one-on-one interview
Interview
Ancillary studies
Media Intervention
View private social media peer support group content
Medical Device Usage and Evaluation
Wear a Fitbit physical activity tracker
Medical Device Usage and Evaluation
Wear a research grade activity measuring device
Questionnaire Administration
Ancillary studies
Reward
Receive badges
Text Message-Based Navigation Intervention
Receive text messages
Text Message-Based Navigation Intervention
Receive reminders
Other Intervention Names
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Eligibility Criteria
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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: Children's Oncology Group (COG) therapeutic trial participation is not required
* Completed all chemotherapy and/or radiation therapy in the last 3-36 months. This includes completion of all oral (e.g., tyrosine kinase inhibitors) and/or maintenance chemotherapy
* Self-report of \< 420 minutes of moderate-to-vigorous physical activity per week as assessed and documented via the study-specific Physical Activity Worksheet. Note: See the case report forms packet on the COG study web page for the study specific Physical Activity Worksheet
* Ambulatory and no known medical contraindications to increasing physical activity
* 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 Spanish or English
* Self-identify as Hispanic, Latino/Latina/Latinx
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
* Participants who were enrolled in ALTE2031 (Step by Step) cannot enroll in ALTE2321. Participants who were enrolled in ALTE2321 Stage 1 (cultural tailoring) cannot enroll to participate in Stage 2 (RCT)
* 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
15 Years
20 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Jason A Mendoza
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Banner Children's at Desert
Mesa, Arizona, United States
Kaiser Permanente Downey Medical Center
Downey, California, 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
Valley Children's Hospital
Madera, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 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
University of Illinois
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 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
Renown Regional Medical Center
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Maimonides Medical Center
Brooklyn, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
El Paso Children's Hospital
El Paso, 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
Children's Hospital of San Antonio
San Antonio, Texas, 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
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
University Pediatric Hospital
San Juan, , Puerto Rico
Countries
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Other Identifiers
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NCI-2024-03609
Identifier Type: REGISTRY
Identifier Source: secondary_id
ALTE2321
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ALTE2321
Identifier Type: OTHER
Identifier Source: secondary_id
ALTE2321
Identifier Type: OTHER
Identifier Source: secondary_id
ALTE2321
Identifier Type: -
Identifier Source: org_study_id
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