Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05863702
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Staying Healthy With Follow-up Care: A Mobile Chatbot Feasibility Study for AYA Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the utilization of a chatbot (Penny) to increase receipt of evidence-based survivorship care in YA survivors of pediatric and YA cancers', 'timeFrame': '1 year', 'description': "We will identify adult survivors of pediatric and YA cancers who have not been seen for follow-up care \\>3 years and evaluate patients' engagement with Penny to schedule return appointments and adhere to recommended life-long ongoing follow-up care according to the NCCN guidelines. Patients will be monitored over a 16-week period to see if they scheduled a follow-up care appointment."}, {'measure': 'Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm', 'timeFrame': '1 year', 'description': 'Percentage of initial responses to the conversation initiated by Penny (opt in vs. opt out) providing permission for text messaging'}, {'measure': 'Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm', 'timeFrame': '1 year', 'description': 'Total number of times patients engage with Penny to schedule follow up appointments, scans, labs, recommendations for other services made at each clinical visit'}, {'measure': 'Number of patients who agree to use Penny and patient engagement overtime in those patients randomized to the Penny arm', 'timeFrame': '1 year', 'description': 'Total number of patients who engage with Penny throughout the study, schedule and are compliant with appointments, scans, labs, and referrals to other services made at each clinical visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Survivorship', 'Pediatric Cancers', 'Young Adult Cancers'], 'conditions': ['Survivorship']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to identify effective strategies to assist survivors of childhood and young adult cancers (diagnosed between birth and age 39) who have not returned for follow-up cancer care for 3 or more years, to reengage with the health care system. The investigator will evaluate the effect of a novel, bidirectional conversational agent ("Penny"), compared to usual care, to assist patients with scheduling appointments, lab work as well as scans and specialty appointments as needed.', 'detailedDescription': 'To achieve this, the investigator will use a two-arm randomized controlled trial to explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from patients. Penny is a conversational agent ("chatbot") that engages patients in real time via text messaging, allowing for bidirectional communication and motivational cues to promote adherence. The chatbot will assist patients who have not been see for cancer follow-up care, with scheduling follow-up appointments, labs, scans, specialty appointments, and monitor compliance with the appointments made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age \\> 18 years), male or female, diagnosed with cancer as a child or as a young adult, between birth and 39 years of age\n* Patient possession of a mobile device that can receive SMS texts\n* Ability to respond to questions and engage with "Penny" in English\n* Ability to provide informed consent to participate in the study\n* Approval of the patient\'s oncology care team for the patient to be involved in the study\n\nExclusion Criteria:\n\n* Anyone who does not meet the inclusion criteria\n* Patients with a history of thyroid cancer or skin cancers'}, 'identificationModule': {'nctId': 'NCT05863702', 'briefTitle': 'Staying Healthy With Follow-up Care: A Mobile Chatbot Feasibility Study for AYA Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Staying Healthy With Follow-up Care: A Feasibility Study Utilizing a Chatbot (Penny) Via Mobile Phones to Increase Compliance With Risk Based Survivorship Care (RBSC) Among Adult Survivors of Pediatric and Young Adult Cancers', 'orgStudyIdInfo': {'id': 'UPCC#: 11923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'Penny text-messaging program', 'interventionNames': ['Behavioral: Penny']}], 'interventions': [{'name': 'Penny', 'type': 'BEHAVIORAL', 'description': 'The chatbot will assist patients who have not been see for cancer follow-up care, with scheduling follow-up appointments, labs, scans, specialty appointments, and monitor compliance with the appointments made.', 'armGroupLabels': ['Penny text-messaging program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}