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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410209
• Other study ID #: ALTE2321
• Secondary ID: NCI-2024-03609AL
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 21, 2024
• Est. completion date: September 15, 2027

Study information

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

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES: I. Use an iterative approach to develop a culturally-tailored multilevel remote-based physical activity (PA) intervention among 20 Latinx adolescent and young adult survivors of childhood cancer (AYA survivors), 10 whose preferred language is English and 10 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. (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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cardiopulmonary fitness	Change in cardiopulmonary fitness will be measured using the 2-Minute Step Test and heart rate monitor.	At baseline and up to final evaluation at 11-12 weeks post-randomization
Other	Change in resting heart rate	Change in resting heart rate will be measured using the 2-Minute Step Test and heart rate monitor.	At baseline and up to final evaluation at 11-12 weeks post-randomization
Primary	Change in moderate to vigorous physical activity (MVPA) measured with a research grade accelerometer	Estimates of intervention effects (mean differences) ascertained from linear mixed models (adjusted for stratification factors) will be presented along with associated confidence intervals and two-sided p-values.	At baseline and up to 11-12 weeks post randomization
Secondary	Change in sedentary time as assessed by a research accelerometer	P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.	At baseline and up to 11-12 weeks post randomization
Secondary	Change in global functioning assessed using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales	P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.	At baseline and up to 11-12 weeks post randomization
Secondary	Change in physical functioning assessed using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales	P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.	At baseline and up to 11-12 weeks post randomization
Secondary	Change in social functioning assessed using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales	P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.	At baseline and up to 11-12 weeks post randomization
Secondary	Change in fatigue assessed by the 18-item PedsQL 4.0 Multidimensional Fatigue Scale in Spanish or English.	P-values will be presented using both the nominal significance level of 0.05 and with adjustments for multiple comparisons using a false discovery rate methodology.	At baseline and up to 11-12 weeks post randomization