ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer

Pediatric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792566
• Other study ID #: 22-156
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Connecticut Children's Medical Center
• Contact: Olga H Toro-Salazar, MD
• Phone: 860-545-9400
• Email: otoro[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• Atomic app
Using the Atomic app to improve physical activity

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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