Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410209
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-07
Brief Title:
A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or LatinoLatina Adolescent and Young Adult Childhood Cancer Survivors Walking Juntos Study
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial tests the impact of a culturally-tailored home-based physical activity program on physical fitness in Hispanic or LatinoLatina 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 LatinoLatina 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 LatinoLatina 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 n85 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 n30 for the intensive intervention phase and n30 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
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 n85 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 n30 for the intensive intervention phase and n30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1CA189955 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189955 |
| NCI-2024-03609 | REGISTRY | None | None |
| ALTE2321 | OTHER | None | None |
| COG-ALTE2321 | OTHER | None | None |
| ALTE2321 | OTHER | None | None |
| R01CA274450 | NIH | None | None |