Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04616651
Status:
TERMINATED
Last Update Posted:
2022-08-11
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Patient-reported Appraisal Outcomes', 'timeFrame': 'Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment', 'description': 'Mean values of the following 5 self-appraisals:\n\n* Cancer related distress \\[scale from 0 (none) to 10 (extreme)\\]\n* Cancer diagnosis anxiety \\[scale from 0 (none) to 10 (extreme)\\]\n* Self-efficacy for question asking \\[scale from 0 (not at all confident) to 10 (extremely confident)\\]\n* Decision preparedness \\[scale from 1 (not at all) to 5 (a great deal)\\]\n* Decision self-efficacy \\[scale from 0 (not at all confident) to 4 (very confident)\\]\n\nThe mean values will be compared by group (pre- vs. post-intervention survey group) using t-tests.'}], 'primaryOutcomes': [{'measure': 'Feasibility of Integrating Chatbot in Clinic', 'timeFrame': 'At the time of scheduling an appointment with cancer physician; one day', 'description': 'The feasibility of integrating an Open to Options (O2O) Chatbot into the clinical workflow, assessed by the number of patients who accept the invitation to receive more information about the study, among all those invited.'}, {'measure': 'Acceptability - Reach', 'timeFrame': 'Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment', 'description': 'Assessed by the number of patients who log-in to the O2O Chatbot program and create an account, among all those who accepted the invitation to receive information.'}, {'measure': 'Acceptability - Uptake', 'timeFrame': 'Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment', 'description': 'Assessed by the number of patients who proceed to view the full Chatbot prototype and generate a summary, among all those who created an account.'}, {'measure': 'Acceptability - Mean Satisfaction Scores', 'timeFrame': 'Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment', 'description': 'Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). Investigators will calculate the mean value (and Standard Deviation) on a 1-5 scale for each question.'}, {'measure': 'Acceptability - Percent of Participants with High Satisfaction Scores', 'timeFrame': 'Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment', 'description': 'Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). For each of the six questions, investigators will calculate the percentage of participants who strongly agree.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chatbot', 'Open to Options (O2O)'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study is designed to study the feasibility and acceptability of the Open to Options (O2O) Chatbot prototype. The O2O program is an existing patient support program with content currently delivered via in-person counseling with a trained mental health professional or via an existing web-based program (Let\'s Talk Treatment Options).The Chatbot is an automated, menu-based agent being developed in this study to extend the reach and accessibility of the O2O program via the Chatbot\'s "virtual coaching".', 'detailedDescription': "This is a pilot study to assess feasibility and acceptability, and to gather preliminary data on how patients with a diagnosis of cancer appraise being prepared for their upcoming visit with a cancer specialist. Participants will be randomized to take a survey either before or after their Chatbot interaction. The surveys collect participants' self-appraisal regarding preparedness for their upcoming appointment with a cancer physician, cancer distress and cancer anxiety. The study will examine whether patients who take the survey after viewing the Chatbot feel more prepared for their upcoming appointment than those who take the survey before the Chatbot interaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a cancer diagnosis\n* Able to speak and read English, and willing to electronically consent\n* Appointment with a Rogel Cancer Center cancer clinician within the next 3 weeks\n* Patient must have a way to access the internet (includes mobile phone)\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Inability to speak or read English\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04616651', 'briefTitle': "Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program", 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': "Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program Cancer Treatment Support in Partnership With the Cancer Support Community", 'orgStudyIdInfo': {'id': 'UMCC 2020.083'}, 'secondaryIdInfos': [{'id': 'HUM00179538', 'type': 'OTHER', 'domain': 'University of Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-Chatbot survey arm', 'description': 'Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.', 'interventionNames': ['Behavioral: Online Survey', 'Behavioral: Chatbot prototype', 'Behavioral: Open to Options (O2O) Program']}, {'type': 'EXPERIMENTAL', 'label': 'Post-Chatbot survey arm', 'description': "Participants will take the self-appraisal survey after interacting with the O2O program via the online Chatbot. (This arm will also answer additional questions regarding participants' satisfaction with the O2O Chatbot.)", 'interventionNames': ['Behavioral: Online Survey', 'Behavioral: Chatbot prototype', 'Behavioral: Open to Options (O2O) Program']}], 'interventions': [{'name': 'Online Survey', 'type': 'BEHAVIORAL', 'otherNames': ['Qualtrix Survey'], 'description': 'Participants respond to online survey questions either before or after using the Chatbot O2O intervention.', 'armGroupLabels': ['Post-Chatbot survey arm', 'Pre-Chatbot survey arm']}, {'name': 'Chatbot prototype', 'type': 'BEHAVIORAL', 'description': 'An online, automated, menu-based agent in which all responses are pre-programmed to be consistent with the existing O2O program. The chat-like responses help guide the participant through a process with the goal of developing a list of questions for their upcoming appointment with a cancer clinician. The session is meant to be completed in one sitting and estimated to take about 45 minutes to complete (including the pre- or post-intervention survey); however, if a participant stops in the middle, they may go back and complete the Chatbot session (or survey).', 'armGroupLabels': ['Post-Chatbot survey arm', 'Pre-Chatbot survey arm']}, {'name': 'Open to Options (O2O) Program', 'type': 'BEHAVIORAL', 'description': 'Evidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments.', 'armGroupLabels': ['Post-Chatbot survey arm', 'Pre-Chatbot survey arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Sarah Hawley, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Support Community', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}