Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05875805
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Telehealth Advance Care Planning Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare Communication: Health Care Climate Questionnaire', 'timeFrame': 'Month 2', 'description': "5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better"}], 'secondaryOutcomes': [{'measure': 'Distress: Distress Thermometer', 'timeFrame': 'Month 2', 'description': '1-item question for distress, range 0-10; higher scores indicate greater distress'}, {'measure': 'Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Month 2', 'description': '7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms'}, {'measure': 'Completion of advance directives', 'timeFrame': 'Throughout the study, up to 2 years', 'description': 'Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older adults', 'Myeloid malignancies', 'Geriatric hematology', 'Serious illness conversations'], 'conditions': ['Myeloid Malignancy', 'Acute Myeloid Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasm', 'Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '36521100', 'type': 'BACKGROUND', 'citation': "LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996."}, {'pmid': '36100548', 'type': 'BACKGROUND', 'citation': "LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10."}]}, 'descriptionModule': {'briefSummary': 'The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.', 'detailedDescription': 'The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion and Exclusion Criteria for Patients\n\nInclusion criteria:\n\n* Age ≥60 years\n* A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)\n* Being managed in the outpatient settings\n* Able to provide informed consent\n* English-speaking\n\nExclusion criteria:\n\n\\- None\n\nInclusion and Exclusion Criteria for Caregivers\n\nInclusion criteria:\n\n* Age ≥18 years\n* Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters"\n* Able to provide informed consent\n* English-speaking\n\nExclusion criteria:\n\n\\- None\n\nInclusion and Exclusion Criteria for Oncology Providers\n\nInclusion criteria:\n\n\\- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit\n\nExclusion criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT05875805', 'acronym': 'SICP RCT', 'briefTitle': 'A Telehealth Advance Care Planning Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UOCPC23038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Serious Illness Care Program', 'description': 'The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).', 'interventionNames': ['Behavioral: Telehealth Serious Illness Care Program']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"', 'interventionNames': ['Other: Education Control']}], 'interventions': [{'name': 'Telehealth Serious Illness Care Program', 'type': 'BEHAVIORAL', 'description': 'The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).', 'armGroupLabels': ['Telehealth Serious Illness Care Program']}, {'name': 'Education Control', 'type': 'OTHER', 'description': 'Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kah Poh Loh, MD', 'role': 'CONTACT', 'email': 'kahpoh_loh@urmc.rochester.edu', 'phone': '585-276-4353'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Kah Poh Loh, MD', 'role': 'CONTACT', 'email': 'Kahpoh_Loh@URMC.Rochester.edu', 'phone': '585-276-4353'}, {'name': 'Becky Gravenstede', 'role': 'CONTACT', 'email': 'becky_gravenstede@urmc.rochester.edu', 'phone': '585-727-4728'}], 'overallOfficials': [{'name': 'Kah Poh Loh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be available for 7 years after study completion', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Department of Medicine, Hematology/Oncology (SMD)', 'investigatorFullName': 'Kah Poh Loh', 'investigatorAffiliation': 'University of Rochester'}}}}