Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-04 @ 9:03 PM
Study NCT ID:
NCT03806192
Status:
TERMINATED
Last Update Posted:
2021-06-23
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Site intermediary and referring MD'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Terminated due to insufficient funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of recruitment', 'timeFrame': 'Up to 1 year'}, {'measure': 'Rate of enrollment', 'timeFrame': 'Up to 1 year'}, {'measure': 'Rate of completion of 5-session intervention', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': "Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])", 'timeFrame': 'Baseline up to 4 months', 'description': 'Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.'}, {'measure': "Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])", 'timeFrame': 'Baseline up to 4 months', 'description': 'Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.'}, {'measure': "Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist", 'timeFrame': 'Baseline up to 4 months', 'description': 'Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.'}, {'measure': "Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)", 'timeFrame': 'Baseline up to 4 months', 'description': 'Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregiver'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': "This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.", 'detailedDescription': 'OUTLINE: Participants are randomized to 1 of 2 groups.\n\nGROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.\n\nGROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.\n\nAfter completion of study, participants are followed up at 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of AML within the recent 2 months\n* Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together\n* Patient must have no other concurrent cancer diagnosis except for basal or squamous cell\n* Caregiver must be able to sustain up to 60 minutes of interaction with patient educator\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together\n* The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell\n* Caregiver cannot sustain up to 60 minutes of interaction with the patient educator\n* Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone'}, 'identificationModule': {'nctId': 'NCT03806192', 'briefTitle': 'Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Field Test of the Partners in Care Program', 'orgStudyIdInfo': {'id': 'RG1003619'}, 'secondaryIdInfos': [{'id': 'NCI-2018-03629', 'type': 'REGISTRY', 'domain': 'NCI / CTRP'}, {'id': '10048', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (psychoeducational counseling sessions via telephone)', 'description': 'Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.', 'interventionNames': ['Behavioral: Telephone-Based Intervention', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (psychoeducational counseling sessions in person)', 'description': 'Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.', 'interventionNames': ['Other: Behavioral, Psychological or Informational Intervention', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Attend psychoeducational counseling sessions via telephone', 'armGroupLabels': ['Group A (psychoeducational counseling sessions via telephone)']}, {'name': 'Behavioral, Psychological or Informational Intervention', 'type': 'OTHER', 'description': 'Attend psychoeducational counseling sessions via video teleconference', 'armGroupLabels': ['Group B (psychoeducational counseling sessions in person)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group A (psychoeducational counseling sessions via telephone)', 'Group B (psychoeducational counseling sessions in person)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Frances Lewis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}