Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT03158467
Status:
WITHDRAWN
Last Update Posted:
2018-09-20
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of ACP for Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Did not enroll', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of surveys completed', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)']}, 'descriptionModule': {'briefSummary': 'We aim to examine the effect of an online advance directive on decisional conflict and quality of life in patients undergoing stem cell transplant. We also aim to assess the effect of palliative care at the time of a sentinel event on quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer Patients Undergoing Stem Cell Transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria for Phase I (primary objective) are as follows:\n\n* Age ≥ 18 years\n* Hematologic malignancy diagnosis including any subset of myeloma, lymphoma, leukemia, or myelodysplastic syndrome\n* Currently scheduled for autologous or allogeneic transplant at the Hospital of the University of Pennsylvania\n\nThe inclusion criteria for Phase II (secondary objective) are as follows:\n\n* Age ≥ 18 years\n* Hematologic malignancy diagnosis including any subset of lymphoma, leukemia, or myelodysplastic syndrome\n* Received an autologous or allogeneic stem cell transplant at the Hospital of the University of Pennsylvania and experienced a sentinel event of either 1) disease relapse,2) severe (Grade III or IV) graft-versus-host disease, or 3) unplanned hospital admission with length of stay greater than 72 hours.\n\nExclusion Criteria:\n\nThe exclusion criteria for Phase I include:\n\n* Inability to read and write English\n* Not serving as the primary decision maker for their health-related decisions\n* Having a non-hematologic malignancy reason for undergoing transplantation (e.g. aplastic anemia)\n\nThe exclusion criteria for Phase II include:\n\n* Not completing participation in Phase I of the study\n* Myeloma diagnosis'}, 'identificationModule': {'nctId': 'NCT03158467', 'briefTitle': 'RCT of ACP for Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot Randomized Control Trial of Advance Care Planning and Triggered Palliative Care for Cancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)', 'orgStudyIdInfo': {'id': 'UPCC 23417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1', 'interventionNames': ['Other: Surveys']}, {'label': 'Phase 2', 'interventionNames': ['Other: Surveys']}], 'interventions': [{'name': 'Surveys', 'type': 'OTHER', 'description': 'Instruments will be administered via the online RedCAP platform. The survey instruments will include a Decision Conflict Scale (DCS), the McGill Quality of Life (MQoL), the Human Connection (THC), and a general demographics questionnaire. Patients will have the opportunity to complete the instruments via a research iPad while in clinic or via a survey link emailed to their private email account.', 'armGroupLabels': ['Phase 1', 'Phase 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pallavi Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}