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

Sponsor

Connecticut Children's Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792566

Collaborator

The Hospital for Sick Children (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer	Other: Atomic app	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

There are 3 phases of this study: 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. 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. "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.There are 3 phases of this study: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. 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. "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)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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.

Other: Atomic app

Using the Atomic app to improve physical activity

Outcome Measures

Primary Outcome Measures

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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

Connecticut Children's Medical Center
The Hospital for Sick Children

Investigators

Principal Investigator: Olga H Toro-Salazar, CT Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Connecticut Children's Medical Center

ClinicalTrials.gov Identifier:

NCT05792566

Other Study ID Numbers:

22-156

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2023