Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-27 @ 2:57 PM
Study NCT ID:
NCT05792566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'There are 3 phases of this study:\n\n1. 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.\n2. 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.\n3. "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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '1 year', 'description': '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.'}, {'measure': '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', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Cancer']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, adolescent and young adults (AYA) ages 10 to 30 years\n* diagnosis with a pediatric cancer diagnosis that requires the treatment of anthracycline therapy\n* Able to speak English fluently (App currently only in English at this time)\n\nExclusion Criteria:\n\n* Pediatric cancer survivors who will not be treated with anthracycline therapy\n* Unable to cooperate with interviewing\n* Unable to understand the content of interviews\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT05792566', 'briefTitle': 'ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '22-156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real life usability testing', 'description': '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.', 'interventionNames': ['Other: Atomic app']}], 'interventions': [{'name': 'Atomic app', 'type': 'OTHER', 'description': 'Using the Atomic app to improve physical activity', 'armGroupLabels': ['Real life usability testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Tiffany L Berthod (Ruiz), MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CT Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}