Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT04733469
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory: Brief COPE Inventory', 'timeFrame': 'Follow-up at 14 days', 'description': 'Total score from 6-24 on 6 Brief COPE Inventory items measuring denial, acceptance (reverse-coded), and self-blame; higher scores indicate less effective coping'}, {'measure': 'Exploratory: PROMIS Anger', 'timeFrame': 'Follow-up at 90 days', 'description': 'Total score from 2-10 on 2 items from the PROMIS Anger item bank; higher scores indicate more anger'}, {'measure': 'Exploratory: PROMIS Positive Affect', 'timeFrame': 'Follow-up at 90 days', 'description': 'Total score from 2-10 on 2 items from the PROMIS Positive Affect item bank; higher scores indicate more positive affect'}, {'measure': 'Exploratory: PROMIS Stress', 'timeFrame': 'Follow-up at 90 days', 'description': 'Total score from 4-20 on 4 items from the PROMIS Stress item bank; higher scores indicate more stress'}, {'measure': 'Exploratory: PROMIS General Self-Efficacy', 'timeFrame': 'Follow-up at 90 days', 'description': 'Total score from 4-20 on 4 items from the PROMIS General Self-Efficacy item bank; higher scores indicate more stress'}, {'measure': 'Exploratory: Medication Adherence', 'timeFrame': 'Follow-up at 90 days', 'description': 'Rating from 1-6 (Very poor to Excellent) for quality of medication adherence in the past 30 days; higher scores indicate better adherence'}, {'measure': 'Exploratory: PROMIS Emotional Support', 'timeFrame': 'Follow-up at 180 days', 'description': 'Total score from 2-10 on 2 items from the PROMIS Emotional Support item bank; higher scores indicate more emotional support'}, {'measure': 'Exploratory: PROMIS Cognitive Function', 'timeFrame': 'Follow-up at 180 days', 'description': 'Total score from 4-20 on 4 items from the PROMIS Cognitive Function item bank; higher scores indicate better cognitive function'}, {'measure': 'Exploratory: PROMIS Meaning and Purpose', 'timeFrame': 'Follow-up at 180 days', 'description': 'Total score from 2-10 on 2 items from the PROMIS Meaning and Purpose item bank; higher scores indicate more meaning and purpose'}, {'measure': 'Exploratory: Quality of Life in Neurologic Disorders (Neuro-QoL) Concern with Death and Dying', 'timeFrame': 'Follow-up at 180 days', 'description': 'Total score from 2-10 on 2 items from the Neuro-QoL Concern with Death and Dying item bank; ; higher scores indicate more concern'}], 'primaryOutcomes': [{'measure': 'Aim 1: Palliative Care Knowledge Scale (PaCKS)', 'timeFrame': 'Post-test of Visit 1, typically day 1', 'description': 'Percentage correct on 13 items; higher scores indicate greater knowledge'}], 'secondaryOutcomes': [{'measure': 'Aim 2a: Palliative Care Attitudes Scale (PCAS-9)', 'timeFrame': 'Post-test of Visit 1, typically day 1', 'description': 'Total score from 0-36; higher scores indicate more positive attitudes'}, {'measure': 'Aim 2b: Palliative Care Utilization', 'timeFrame': 'Up to 90 days', 'description': 'Utilization of palliative care (presence/absence)'}, {'measure': 'Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions', 'timeFrame': 'Follow-up at 14, 90, and 180 days', 'description': 'Total score from 8-40 on 8 items from PROMIS self-efficacy for managing symptoms and self-efficacy for managing emotions items banks; higher scores indicate greater self-efficacy'}, {'measure': 'Aim 3b: PROMIS Emotional Distress', 'timeFrame': 'Follow-up at 14, 90, and 180 days', 'description': 'Total score from 8-40 on 8 items from the PROMIS Depression and Anxiety item banks; higher scores indicate greater symptom severity'}, {'measure': 'Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical', 'timeFrame': 'Follow-up at 14, 90, and 180 days', 'description': 'Total score from 0-60 on 6 ESAS ratings of pain, tiredness, drowsiness, nausea, poor appetite, and difficulty breathing; higher scores indicate greater symptom severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Neoplasm Malignant']}, 'descriptionModule': {'briefSummary': "Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult, age 18 or older\n2. Meets criteria for 2a or 2b. 2a) The patient's doctor believes they may be appropriate for palliative cancer care OR 2b) The patient has a new diagnosis, recurrence, or progression of cancer in the past 90 days AND any of the following:\n\n * Advanced cancer, such as:\n\n * Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell\n * Breast Cancer: Stage IV\n * Gastrointestinal (GI) Cancers: Unresectable stage III or stage IV\n * Genitourinary (GU) Cancers: Stage IV\n * Melanoma: Stage IV\n * Hematologic Malignancies\n\n * Leukemia (e.g., acute myeloid leukemia \\[AML\\], acute lymphoblastic leukemia \\[ALL\\], chronic myeloid leukemia (CML), chronic lymphocytic leukemia \\[CLL\\]): advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age\n * Lymphoma: Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma Multiple Myeloma: elevated β2-microglobulin, albumin \\<3.5, PCLI \\>1%, CRP \\>6µg/mL, elevated LDH, plasmablastic morphology, or abnormal chromosome 13\n * Advanced heart, lung, renal (kidney), or liver disease\n * Two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety\n3. Patient can understand spoken or written English\n4. Patient receives care in southeast Louisiana\n\nExclusion Criteria:\n\n* Known history of receiving specialty palliative care or hospice\n* Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study\n* Unlikely to complete any follow-up surveys"}, 'identificationModule': {'nctId': 'NCT04733469', 'acronym': 'EMPOWER 3', 'briefTitle': 'EMPOWER 3: Improving Palliative Care Health Literacy and Utilization', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'EMPOWER 3: Improving Palliative Care Health Literacy and Utilization', 'orgStudyIdInfo': {'id': '134579-RSG-20-058-01-PCSM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimedia Psychoeducational Intervention + Enhanced Usual Care', 'description': 'Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care', 'interventionNames': ['Behavioral: Multimedia Psychoeducational Intervention', 'Behavioral: Enhanced Usual Care']}, {'type': 'OTHER', 'label': 'Enhanced Usual Care', 'description': 'Control participants receive Enhanced Usual Care', 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'Multimedia Psychoeducational Intervention', 'type': 'BEHAVIORAL', 'description': "The Multimedia Psychoeducational Intervention includes a multimedia educational video plus additional resources to reinforce the video content. The Multimedia Psychoeducational Intervention includes the following:\n\n* A multimedia educational video about palliative care that is individually tailored to each patient's level of education and health literacy\n* Take-home and online copies of the video for repeat viewing\n* A video summary\n* A question prompt list patients can use to ask clinicians more questions about palliative care\n* Contact information and brochures for local palliative care programs", 'armGroupLabels': ['Multimedia Psychoeducational Intervention + Enhanced Usual Care']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'description': 'Enhanced Usual Care refers to usual care plus minor enhancement to improve quality and standardization. Enhanced Usual Care includes the following:\n\n* Usual care\n* A packet of flyers and handouts with general information on psychosocial oncology services derived from the American Society of Clinical Oncology (ASCO), Center to Advance Palliative Care (CAPC), and American Cancer Society (ACS)', 'armGroupLabels': ['Enhanced Usual Care', 'Multimedia Psychoeducational Intervention + Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Hoerger, PhD, MSCR, MBA', 'role': 'CONTACT'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Hoerger, PhD, MSCR, MBA', 'role': 'CONTACT'}], 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Michael Hoerger, PhD, MSCR, MBA', 'role': 'CONTACT', 'email': 'mhoerger@tulane.edu', 'phone': '504-314-7545'}], 'overallOfficials': [{'name': 'Michael Hoerger, PhD, MSCR, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'By the study end date, available for at least 3 years.', 'ipdSharing': 'YES', 'description': 'IPD can be shared with other researchers upon completing a data usage agreement signed by all participating universities.', 'accessCriteria': 'Contact the Study PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'University Medical Center-New Orleans', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology, Psychiatry, and Oncology', 'investigatorFullName': 'Michael Hoerger, PhD, MSCR', 'investigatorAffiliation': 'Tulane University'}}}}