Clinical trial NCT06410209: 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
Official title: Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
First posted: 2024-05-13
Enrollment: 190
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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: 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

Primary outcomes:
measure: Moderate to vigorous physical activity (MVPA)
timeFrame: Baseline to 11-12 weeks post randomization
Secondary outcomes:
measure: Sedentary time
timeFrame: Baseline to 11-12 weeks post randomization
measure: Global functioning
timeFrame: Baseline to 11-12 weeks post randomization
measure: Physical functioning
timeFrame: Baseline to 11-12 weeks post randomization
measure: Social functioning
timeFrame: Baseline to 11-12 weeks post randomization
measure: Fatigue
timeFrame: Baseline to 11-12 weeks post randomization
Other outcomes:
measure: Change in cardiopulmonary fitness
timeFrame: At baseline and up to final evaluation at 11-12 weeks post-randomization
measure: Change in resting heart rate
timeFrame: At baseline and up to final evaluation at 11-12 weeks post-randomization
Locations:
city: Mesa
country: United States
facility: Banner Children's at Desert
state: Arizona
city: Downey
country: United States
facility: Kaiser Permanente Downey Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Long Beach
country: United States
facility: Miller Children's and Women's Hospital Long Beach
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Indianapolis
country: United States
facility: Ascension Saint Vincent Indianapolis Hospital
state: Indiana
city: Des Moines
country: United States
facility: Blank Children's Hospital
state: Iowa
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Omaha
country: United States
facility: Children's Hospital and Medical Center of Omaha
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Legacy Emanuel Children's Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State Children's Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: BI-LO Charities Children's Cancer Center
state: South Carolina
city: Knoxville
country: United States
facility: East Tennessee Childrens Hospital
state: Tennessee
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: The Children's Hospital at TriStar Centennial
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: El Paso
country: United States
facility: El Paso Children's Hospital
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Children's Hospital of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital of South Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Children's Oncology Group
name: Jason A Mendoza
role: PRINCIPAL_INVESTIGATOR
References: