Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-28 @ 11:38 PM
Study NCT ID:
NCT03028961
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record', 'timeFrame': 'Up to BMT day 0', 'description': 'The chi-square (X\\^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation', 'timeFrame': 'Up to BMT day 0', 'description': 'The X\\^2 test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.'}, {'measure': 'Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results', 'timeFrame': 'Up to BMT day 0', 'description': 'Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty). Scores from each group will be compared by t-tests.'}, {'measure': 'Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS', 'timeFrame': 'within 28 days of ACP completion', 'description': 'Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.'}, {'measure': 'Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS', 'timeFrame': 'within 28 days of ACP completion', 'description': 'Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Scores from each group will be compared by t-tests. Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advance Directives', 'Bone Marrow Transplant']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.\n\nCompletion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.', 'detailedDescription': 'PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.\n\nII. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.\n\nIII. To explore patient understanding of and satisfaction with the ACP tool in each group.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.\n\nGROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the California (CA) Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.\n\nAfter completion of study, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All BMT patients at Stanford who are adults and give consent\n\nExclusion Criteria:\n\n* Less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT03028961', 'acronym': 'BMTSLPRCT', 'briefTitle': 'Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients', 'orgStudyIdInfo': {'id': 'BMT313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Stanford Letter, interview)', 'description': 'Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.', 'interventionNames': ['Other: Stanford Letter', 'Other: Interview', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (traditional advance directive, interview)', 'description': 'Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.', 'interventionNames': ['Other: Interview', 'Other: Questionnaire Administration', 'Other: CA Advance Health Care Directive Form']}], 'interventions': [{'name': 'Stanford Letter', 'type': 'OTHER', 'otherNames': ['Communication Intervention'], 'description': 'Receive and complete the Stanford Letter', 'armGroupLabels': ['Group I (Stanford Letter, interview)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Undergo semi-structured, research staff-led interview', 'armGroupLabels': ['Group I (Stanford Letter, interview)', 'Group II (traditional advance directive, interview)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (Stanford Letter, interview)', 'Group II (traditional advance directive, interview)']}, {'name': 'CA Advance Health Care Directive Form', 'type': 'OTHER', 'otherNames': ['Communication Intervention'], 'description': 'Receive and complete the CA Advance Health Care Directive Form', 'armGroupLabels': ['Group II (traditional advance directive, interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Lori Muffly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}