- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792566
ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer
January 6, 2026 updated by: Tiffany Ruiz, Connecticut Children's Medical Center
Development and Usability Testing of the ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Children, Adolescent and Young Adults (AYA) Survivors of Childhood Cancer
Development and Usability Testing of the ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Children, Adolescent and Young Adults (AYA) survivors of childhood cancer
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this program of research is to (1) determine the adaptations required of a pre-existing mobile fitness app to tailor it for childhood cancer survivors using a behavioral theory driven approach (Social Cognitive Theory) and (2) develop and evaluate the usability of the adapted mobile app using the Technology Assessment Model.
The Technology Assessment Model (TAM), which theorizes the individuals' intentions to use information technology, is based on two driving factors: perceived usefulness and perceived ease of use.
Future studies will evaluate the feasibility and effectiveness of this app.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children, adolescent and young adults (AYA) ages 10 to 30 years
- diagnosis with a pediatric cancer diagnosis that requires the treatment of anthracycline therapy
- Able to speak English fluently (App currently only in English at this time)
Exclusion Criteria:
- Pediatric cancer survivors who will not be treated with anthracycline therapy
- Unable to cooperate with interviewing
- Unable to understand the content of interviews
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real life usability testing
B) "Real Life" Usability Testing.
We will conduct a "real life" usability test in a sample of 6 pediatric cancer survivors.
EX@HOME: Patients will perform an individualized aerobic and resistance exercise intervention, choosing from a list of PA, progressing from light to moderate-to-vigorous intensity totaling 30-45 min/d, 4-5 weekly/wk.
for 4 weeks.
The social-cognitive-theory-based mobile app will support the exercise intervention.
One-on-one messaging chats with a PA coach through the mobile app will facilitate exercise goal establishment and attainment.
|
Using the Atomic app to improve physical activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of use and user errors will be documented for each individual during usability testing, by completing several tasks while navigating the mobile app platform
Time Frame: 1 year
|
The interviewers will record how well the participants are able to navigate the task by recording either "easy to find", "with prompting", or "unable to complete", representing completing the task completely on their own, with help from the interviewer, or unable to complete after prompting from the interviewer.
The frequency of user errors will be calculated.
|
1 year
|
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The Acceptability E-Scale is six-item tool that has been validated for assessing the usability, acceptability, and satisfaction of web based programs with statements ranked on a five point scale from very difficult to very easy
Time Frame: 1 year
|
Acceptability of a program has been proposed to be represented by obtaining a score of 24 or more.81
Good internal consistency (alpha = 0.76) as well as good initial validity has been reported.
The acceptability E-scale will be administered at the completion of the "in laboratory" testing and "real-life" usability testing.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tiffany L Berthod (Ruiz), MSN, CT Children's Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2023
Primary Completion (Actual)
August 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 28, 2023
First Posted (Actual)
March 31, 2023
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 6, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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