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Clinical Trial NCT06410209 for Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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
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.
Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
- ALTE2321
- NCI-2024-03609 (Registry Identifier) (CTRP (Clinical Trial Reporting Program))
- ALTE2321 (Other Identifier) (Children's Oncology Group)
- COG-ALTE2321 (Other Identifier) (DCP)
- ALTE2321 (Other Identifier) (CTEP)
- R01CA274450 (U.S. NIH Grant/Contract)
- UG1CA189955 (U.S. NIH Grant/Contract)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalStage 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 |
ExperimentalStage 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 |
Active ComparatorStage 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Moderate to vigorous physical activity (MVPA) | MVPA will be measured with a research grade accelerometer. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Sedentary time | Sedentary time will be measured with a research grade accelerometer. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
Global functioning | Global functioning will be measured using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
Physical functioning | Physical functioning will be measured using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
Social functioning | Social functioning will be measured using Spanish language versions of the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
Fatigue | Fatigue will be measured using the18-item PedsQL 4.0 Multidimensional Fatigue Scale in Spanish or English. Will report the mean change from baseline to the 11-12-week post randomization timepoint by trial arm alongside corresponding confidence intervals estimated under a linear mixed effects model. | Baseline to 11-12 weeks post randomization |
- 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
- 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
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