NCT05792566

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

March 10, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

March 10, 2023

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 year

Study Arms (1)

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.

Other: Atomic app

Interventions

Using the Atomic app to improve physical activity

Real life usability testing

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Tiffany L Berthod (Ruiz), MSN

    CT Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 31, 2023

Study Start

June 12, 2023

Primary Completion

August 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations