Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-30 @ 5:17 AM
Study NCT ID:
NCT05641961
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2022-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge questionnaire score', 'timeFrame': 'Up to 4 months', 'description': 'The knowledge of the participant will be measured using a 12-item questionnaire that assesses the awareness of their treatment and health issues in four categories: (1) diagnosis, (2) treatment, (3) risks, and (4) recommended follow-up. A scoring system has been devised which will give a score to each questionnaire out of 100 possible points. The change in participants knowledge scores \\>=20 points from baseline will be reported.'}], 'secondaryOutcomes': [{'measure': 'System usability scale (SUS) score > 68', 'timeFrame': 'Up to 2 months', 'description': "System Usability Scale (SUS) consists of a 10-item survey with five response options from Strongly agree to Strongly disagree. The scoring of positive questions is done as follows: The user's score is reduced by one point. For example, if the user's score is 4 for question 5, then the outcome score will be 3. The scoring of negative questions is done as follows: The user's score is subtracted from 5. For example, if the user's score is 3 for question 4, then the new score will be 2. After all the scores are determined, the sum of the scores is multiplied by 2.5 to make the range between 0 and 100. Scores above 68 are considered above average. The proportion of participants with an acceptable usability score \\> 68 will be reported."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cancer', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. The survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. The ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app.\n\nSECONDARY OBJECTIVE:\n\nI. To validate the usability and effectiveness of the survivorship mobile application.\n\nOUTLINE:\n\nParticipants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants then use the survivorship app for 4 months on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Survivors of childhood cancer attending Survivorship Clinic at University of California, San Francisco (UCSF) OR caregivers of a childhood cancer survivor attending Survivorship Clinic at UCSF.\n* Must have a mobile device (smartphone or smart-tablet) with service plan.\n* Must have ability to read, write, and understand English language.\n\nExclusion Criteria:\n\n* An individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.'}, 'identificationModule': {'nctId': 'NCT05641961', 'briefTitle': 'Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Utilizing a Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care', 'orgStudyIdInfo': {'id': '220813'}, 'secondaryIdInfos': [{'id': 'NCI-2022-09452', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Survivorship Mobile Application', 'description': "Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants enrolled in this study will be asked to complete two self-administered questionnaires at 4 time points. Questionnaires will be designed and made available electronically, to be completed on the participant's personal mobile device (e.g., mobile phone).", 'interventionNames': ['Behavioral: Survivorship mobile application', 'Other: Questionnaires']}], 'interventions': [{'name': 'Survivorship mobile application', 'type': 'BEHAVIORAL', 'otherNames': ['Survivorship App'], 'description': 'Mobile phone application', 'armGroupLabels': ['Survivorship Mobile Application']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Questionnaires assessing cancer knowledge and system usability will be delivered to participants via Survivorship App', 'armGroupLabels': ['Survivorship Mobile Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patricia Murphy, RN', 'role': 'CONTACT', 'email': 'Patricia.Murphy@ucsf.edu', 'phone': '415-476-2700'}, {'name': 'Robert Goldsby, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Patricia Murphy, RN', 'role': 'CONTACT', 'email': 'Patricia.Murphy@ucsf.edu', 'phone': '(415) 476-2700'}], 'overallOfficials': [{'name': 'Robert Goldsby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swim Across America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}