Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03874195
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2019-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care For Me (PCforMe)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative\\_care). Intervention Arm subjects will receive access to PCforMe.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System usability as measured by the system usability scale', 'timeFrame': '1 hour', 'description': 'To determine usability, the System Usability Scale will be administered to each participate. As described by usability.gov: "The participant\'s scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the participant\'s results involves "normalizing" the scores to produce a percentile ranking." The original scale is a 10-item, 5-point Likert scale.'}], 'secondaryOutcomes': [{'measure': 'Change in Palliative Care knowledge', 'timeFrame': 'Baseline, up to 1 hour', 'description': 'Regarding the change in knowledge outcome, Two-side P value of \\<0.05 will infer significance. The Palliative Care Knowledge instrument is a 4-item, multiple choice assessment of palliative care knowledge. Only one answer is correct. A change in knowledge of Palliative Care will be determined based on the answer provided in the follow-up assessment'}, {'measure': 'Change in Perceived Efficacy for the Patient-Physician Interaction (PEPPI)', 'timeFrame': 'Baseline, up to 1 hour', 'description': 'Change in PEPPI will be determined using 5-point Likert response - 1 being Not at all Confident and 5 being Very Confident'}, {'measure': 'Change in single-item Prepared item', 'timeFrame': 'Baseline, up to 1 hour', 'description': '"I feel prepared for my palliative care appointment" (5-point Likert response - Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palliative Care']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the usability of PCforMe, a web-based preparation and engagement tool about palliative care, during a pre-visit pilot trial in outpatient palliative care at the Duke Cancer Institute Palliative Care Clinic.', 'detailedDescription': 'The Investigator will 1:1 randomize patients to an Active Control arm or Intervention arm. Both arms will receive a tablet computer (iPad or Galaxy Tab based on preference) connected to the internet with disposable headphones to use for up to 30 minutes. Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative\\_care). Intervention Arm subjects will receive access to PCforMe.\n\nPCforMe is an online, web-based, interactive tool to prepare patients for a clinical palliative care encounter. PCforMe is accessible through www.pcforme.org. It does not collect any patient information, including identifiers (e.g. name, email address, disease, location) or health information (e.g. disease, symptom severity or location). The system uses a combination of animated videos and user-answered questions to generate a "Palliative Care Passport", which is a summary of information entered into the system. Research staff will print out the Passport for patients and hand it to them prior to the appointment.\n\nQueries for users include standard-of-care questions asked by palliative care clinicians, including areas that patients want to more learn about. No diagnoses, medication advice, or clinical assessments are made or given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential participants will be identified by reviewing clinic appointment listings in EPIC (e.g., diagnosis, date of diagnosis, date of clinic appointment, physician), and deemed eligible by the RA by meeting the following criteria:\n\n * Age \\>18\n * capacity to give consent\n * has a scheduled outpatient visit (initial consult) with a palliative care provider\n * ability to speak and understand English\n\nExclusion Criteria:\n\n* Not meeting the inclusion requirements'}, 'identificationModule': {'nctId': 'NCT03874195', 'briefTitle': 'Palliative Care For Me (PCforMe)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Usability Testing of a Web-based Tool to Prepare Patients for Palliative Care', 'orgStudyIdInfo': {'id': 'Pro00075906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care - www.palliativedoctors.org; getpalliativecare.org; and Wikipedia "Palliative Care" https://en.wikipedia.org/wiki/Palliative care).', 'interventionNames': ['Behavioral: Access to three nationally-recognized Palliative Care websites for review']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention Arm subjects will receive access to PCforMe.', 'interventionNames': ['Behavioral: Access to PCforMe for review']}], 'interventions': [{'name': 'Access to PCforMe for review', 'type': 'BEHAVIORAL', 'otherNames': ['Knowledge of Palliative Care', 'Prepartion for Palliative Care appointment', 'Confidence in Palliative Care discussion with provider'], 'description': 'Intervention Arm subjects will receive access to PCforMe.', 'armGroupLabels': ['Intervention']}, {'name': 'Access to three nationally-recognized Palliative Care websites for review', 'type': 'BEHAVIORAL', 'otherNames': ['Knowledge of Palliative Care', 'Prepartion for Palliative Care appointment', 'Confidence in Palliative Care discussion with provider'], 'description': 'Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Arif Kamal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Health Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}