Pediatric CancerNCT05792566
ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer
A study testing Atomic app in people with Pediatric Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Atomic app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: 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
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Atomic app
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomic appOther
Using the Atomic app to improve physical activity
| Study group | Role | What they receive |
|---|---|---|
| Real life usability testing | Experimental | 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. Receives: Other: Atomic app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 1 year
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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start12 Jun 2023
- Primary completion31 Aug 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There are 3 phases of this study: 1. Participants will be shown features from the ATOMIC app and asked to discuss what features they like and what additional content, features and functionalities they would want for a specific PA app focused on pediatric cancer survivors. This information will be used to adapt the app. 2. Use a "talking aloud" approach as they encounter issues with completing a series of tasks related to using the app. The design team and the research team will develop a new iteration of the platform that will then be vetted by our app creation committee and the next interview participants. 3. "Real Life" Usability Testing. 6 pediatric cancer survivors. Individualized aerobic and resistance exercise intervention. 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Tiffany Ruiz, Connecticut Children's Medical Center
- Investigators
- Tiffany L Berthod (Ruiz), MSN, Principal investigator, CT Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792566
- Sponsor's protocol ID
- 22-156
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05792566
- Acronym / sponsor ID
- 22-156
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are 3 phases of this study: 1. Participants will be shown features from the ATOMIC app and asked to discuss what features they like and what additional content, features and functionalities they would want for a specific PA app focused on pediatric cancer survivors. This information will be used to adapt the app. 2. Use a "talking aloud" approach as they encounter issues with completing a series of tasks related to using the app. The design team and the research team will develop a new iteration of the platform that will then be vetted by our app creation committee and the next interview participants. 3. "Real Life" Usability Testing. 6 pediatric cancer survivors. Individualized aerobic and resistance exercise intervention. 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.
| Arm | Type | Receives |
|---|---|---|
| Real life usability testing | Experimental | Other: Atomic appB) "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. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomic appUsing the Atomic app to improve physical activity | Other | Real life usability testing |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany L Berthod (Ruiz), MSN principal investigator
CT Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atomic app in people with Pediatric Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.