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NCT06410209PHASE2Recruiting

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

Children's Oncology Group

Start Date

10/15/2024

Completion Date

9/15/2027

Summary

This clinical trial tests the impact of a culturally-tailored home-based physical activity program on physical fitness in Hispanic or Latino/Latina adolescent and young adult (AYA) childhood cancer survivors. After treatment for cancer, some AYA survivors experience long-term effects from the cancer and its treatment including weight gain, fatigue and decreased physical fitness. Hispanic or Latino/Latina survivors may have a higher risk of these effects compared to non-Hispanics. Regular physical activity helps maintain healthy weight, energy levels and overall health. Participating in a culturally-tailored home-based physical activity program may help increase physical activity in Hispanic or Latino/Latina AYA childhood cancer survivors.

Detailed Description

PRIMARY OBJECTIVES: 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 PA tracker only) with respect to the primary outcome of moderate to vigorous physical activity (MVPA) measured with a validated, wearable Fitbit PA tracker over 12 weeks among a separate group of 170 Latinx AYA survivors whose preferred language is Spanish or English (n=85 per randomization group) and who do not meet PA guidelines at timepoint (T) 1. 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 group relative to control group with respect to decreasing sedentary time as assessed by a Fitbit PA tracker. II. Evaluate potential efficacy of randomization to the active intervention group with respect to improvement in reported health-related quality of life. EXPLORATORY OBJECTIVES: I. Evaluate potential efficacy of randomization to the active intervention group 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 participants in the intervention Group n=12-15 for the intensive intervention phase and n=12-15 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, receive badges, and participate in a monthly Zoom meeting with their peers to discuss physical activity for 12 weeks. Patients may optionally choose a physical activity partner. Partners wear a Fitbit physical activity tracker and receive educational materials about supporting the participant. 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. In addition, patients may continue to have their physical activity partner support them as in the Intensive Phase. GROUP II (CONTROL): Patients wear a Fitbit physical activity tracker daily for 12 weeks.

Eligibility Criteria

Age Range: 15 years to 20 years

Inclusion Criteria: * Patient must be ≥ 15 years and \< 21 years at the time of enrollment * 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: Certain stem cell transplant procedures are excluded. Reminder: 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: * Patients with previous allogeneic 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 * 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

Interventions

OTHER

Discussion

OTHER

Goal Setting

OTHER

Interview

OTHER

Interview

OTHER

Media Intervention

OTHER

Medical Device Usage and Evaluation

OTHER

Medical Device Usage and Evaluation

OTHER

Questionnaire Administration

OTHER

Reward

OTHER

Text Message-Based Navigation Intervention

OTHER

Text Message-Based Navigation Intervention

Interested in This Trial?

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Conditions

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Locations

Banner Children's at Desert

Mesa, Arizona 85202

United States

Phoenix Childrens Hospital

Phoenix, Arizona 85016

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202-3591

United States

Kaiser Permanente Downey Medical Center

Downey, California 90242

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California 90806

United States

Mattel Children's Hospital UCLA

Los Angeles, California 90095

United States

Valley Children's Hospital

Madera, California 93636

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California 94609

United States

Kaiser Permanente-Oakland

Oakland, California 94611

United States

Rady Children's Hospital - San Diego

San Diego, California 92123

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Yale University

New Haven, Connecticut 06520

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware 19803

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida 33908

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida 32207

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida 33136

United States

Miami Cancer Institute

Miami, Florida 33176

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Arnold Palmer Hospital for Children

Orlando, Florida 32806

United States

Nemours Children's Hospital

Orlando, Florida 32827

United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida 32504

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida 33607

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia 30329

United States

Memorial Health University Medical Center

Savannah, Georgia 31404

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois 60611

United States

University of Illinois

Chicago, Illinois 60612

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana 46260

United States

Blank Children's Hospital

Des Moines, Iowa 50309

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky 40536

United States

Children's Hospital New Orleans

New Orleans, Louisiana 70118

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

Sinai Hospital of Baltimore

Baltimore, Maryland 21215

United States

Walter Reed National Military Medical Center

Bethesda, Maryland 20889-5600

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota 55404

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada 89102

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada 89109

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada 89135

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada 89144

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Saint Peter's University Hospital

New Brunswick, New Jersey 08901

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87106

United States

Maimonides Medical Center

Brooklyn, New York 11219

United States

Montefiore Medical Center - Moses Campus

The Bronx, New York 10467

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Legacy Emanuel Children's Hospital

Portland, Oregon 97227

United States

Penn State Children's Hospital

Hershey, Pennsylvania 17033

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania 19134

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina 29605

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee 37916

United States

Saint Jude Children's Research Hospital

Memphis, Tennessee 38105

United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee 37203

United States

Dell Children's Medical Center of Central Texas

Austin, Texas 78723

United States

Driscoll Children's Hospital

Corpus Christi, Texas 78411

United States

Medical City Dallas Hospital

Dallas, Texas 75230

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas 75390

United States

El Paso Children's Hospital

El Paso, Texas 79905

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas 77030

United States

M D Anderson Cancer Center

Houston, Texas 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas 78207

United States

Methodist Children's Hospital of South Texas

San Antonio, Texas 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington 99204

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin 53226

United States

University Pediatric Hospital

San Juan, 00926

Puerto Rico