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Mobile Health + Social Media for Cancer Survivors

Bethesda, MD
Phase 3
Waitlist Available
Led By Nina S Kadan-Lottick
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
Ambulatory and no known medical contraindications to increasing physical activity
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
Must not have
Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether adding a mobile health and social media intervention to a physical activity tracker can help adolescent and young adult childhood cancer survivors be more physically active.

See full description
Who is the study for?
This trial is for adolescent and young adult childhood cancer survivors who've had chemotherapy or radiation, are expected to live more than a year, can walk, and have no medical issues preventing increased physical activity. They must be in remission, finished treatment within the last 3-36 months, do less than 420 minutes of exercise per week, and be able to use devices like Fitbits and smartphones.Check my eligibility
What is being tested?
The StepByStep Study compares two programs: one that combines mobile health tools with social media to encourage physical activity versus just wearing an activity tracker. The goal is to see which method better increases physical activity levels over time and how this affects overall health and quality of life.See study design
What are the potential side effects?
Since the interventions involve non-medical methods such as goal setting, education via various media platforms including telephone support, there are no direct side effects like those associated with medications. However, increasing physical activity could lead to muscle soreness or injury if not done carefully.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk and have no health issues preventing me from being more active.
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My first cancer diagnosis is still in remission.
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My cancer treatment included chemotherapy or radiation.
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I finished my cancer treatment between 3 to 36 months ago.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant nor planning to become pregnant in the next year.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation
Secondary study objectives
Body mass index (BMI)
Cardiopulmonary fitness
Glucose
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group (educational materials, goal set, Fitbit)Experimental Treatment6 Interventions
See outline
Group II: Control Group (educational materials, Fitbit)Active Control2 Interventions
Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FitBit
2017
N/A
~480
Telephone-Based Intervention
2017
Completed Phase 2
~3400

Find a Location

Closest Location:Children's Hospital Medical Center of Akron· Akron, OH· 111 miles

Who is running the clinical trial?

MedStar Georgetown University HospitalOTHER
5 Previous Clinical Trials
22,485 Total Patients Enrolled
Yale UniversityOTHER
1,953 Previous Clinical Trials
3,043,180 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
465 Previous Clinical Trials
240,276 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,049 Total Patients Enrolled
3 Trials studying Blood Cancers
612 Patients Enrolled for Blood Cancers
Nina S Kadan-LottickPrincipal InvestigatorChildren's Oncology Group

Media Library

Multi-component mobile health and social media physical activity intervention Clinical Trial Eligibility Overview. Trial Name: NCT04089358 — Phase 3
Blood Cancers Research Study Groups: Intervention group (educational materials, goal set, Fitbit), Control Group (educational materials, Fitbit)
Blood Cancers Clinical Trial 2023: Multi-component mobile health and social media physical activity intervention Highlights & Side Effects. Trial Name: NCT04089358 — Phase 3
Multi-component mobile health and social media physical activity intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04089358 — Phase 3
~58 spots leftby Dec 2025
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