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Behavioural Intervention

Mobile Health and Social Media Intervention for Cancer Survivors

Phase 2
Recruiting
Led By Jason A Mendoza
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 11-12 weeks post randomization
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if a specialized home exercise program can improve physical fitness in Hispanic or Latino/Latina young cancer survivors. After cancer treatment, survivors may face issues like weight gain and fatigue.

Who is the study for?
This trial is for Hispanic or Latino/Latina AYA childhood cancer survivors, aged 15-21 years, who are in remission but have had chemotherapy and/or radiation. They should be ambulatory, with no medical issues preventing increased physical activity, not very active currently (<420 minutes of moderate exercise per week), and able to use electronic devices.
What is being tested?
The study tests a home-based physical activity program tailored for Hispanic or Latino/Latina AYA cancer survivors. It includes text messages, device usage (like Fitbit), questionnaires, rewards for goals met, interviews about their experience, and media interventions to improve fitness.
What are the potential side effects?
Since the intervention involves increasing physical activity through guidance rather than medication or invasive procedures, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 15 and 20 years old.
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My first cancer diagnosis is in remission and I am enrolling while it remains so.
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My cancer treatment included chemotherapy or radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 11-12 weeks post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 11-12 weeks post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Moderate to vigorous physical activity (MVPA)
Secondary study objectives
Fatigue
Global functioning
Physical functioning
+2 more
Other study objectives
Change in cardiopulmonary fitness
Change in resting heart rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Stage 2, Group I (Fitbit, goal setting, peer support)Experimental Treatment7 Interventions
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: Stage 1 (Fitbit, interview)Experimental Treatment6 Interventions
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.
Group III: Stage 2, Group II (Fitbit)Active Control3 Interventions
Patients wear a Fitbit physical activity tracker daily for 12 weeks.

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Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,808 Total Patients Enrolled
Jason A MendozaPrincipal InvestigatorChildren's Oncology Group
~127 spots leftby Sep 2027