Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
Study NCT ID:
NCT05723250
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Care Coordination Educational Intervention Study for Patients from Rural Areas with Early Stage Cancer
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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Care Coordination Instrument Score', 'timeFrame': 'Baseline and 4 months', 'description': 'Participants complete the Care Coordination Instrument (CCI), a 29-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 3 to Strongly Disagree = 0). A total score is generated by summing the item scores; possible total scores range from 0-87. Higher scores represent a greater perception of care coordination.'}], 'secondaryOutcomes': [{'measure': 'Cancer Knowledge', 'timeFrame': 'Baseline and 4 months', 'description': 'Participants complete the Cancer Knowledge Assessment Test (C-KAT). The test includes 5 multiple choice items. A total score is generated by summing the number of correct responses; total scores range from 0-5. Higher scores represent greater cancer knowledge.'}, {'measure': 'Satisfaction with Educational Videos', 'timeFrame': '4 months', 'description': 'Participants in the baseline intervention group complete the Satisfaction and Acceptability Questionnaire. This 5-item questionnaire assesses how helpful and easily accessible the educational videos were. There is also an open-ended question for other feedback. Answering yes to the items indicates greater satisfaction and ease of use.'}, {'measure': 'Self-Advocacy Score', 'timeFrame': 'Baseline and 4 months', 'description': 'Participants complete the Cancer Self-Advocacy Scale, a 20-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 6 to Strongly Disagree = 1). A total score is generated by summing the item scores; possible total scores range from 20-120. Higher scores represent greater self-advocacy skills.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['healthcare delivery', 'care coordination', 'early stage cancer', 'educational intervention'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31964391', 'type': 'BACKGROUND', 'citation': "Okado I, Cassel K, Pagano I, Holcombe RF. Development and psychometric evaluation of a questionnaire to measure cancer patients' perception of care coordination. BMC Health Serv Res. 2020 Jan 21;20(1):52. doi: 10.1186/s12913-020-4905-4."}, {'pmid': '32216713', 'type': 'BACKGROUND', 'citation': "Okado I, Cassel K, Pagano I, Holcombe RF. Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. JCO Oncol Pract. 2020 Aug;16(8):e726-e733. doi: 10.1200/JOP.19.00509. Epub 2020 Mar 27."}, {'pmid': '32970231', 'type': 'BACKGROUND', 'citation': 'Okado I, Pagano I, Cassel K, Holcombe RF. Perceptions of care coordination in cancer patient-family caregiver dyads. Support Care Cancer. 2021 May;29(5):2645-2652. doi: 10.1007/s00520-020-05764-8. Epub 2020 Sep 24.'}]}, 'descriptionModule': {'briefSummary': "Care Coordination is an essential component of cancer care delivery. Many patients experience poor care coordination. In this study, we hypothesize that provision of a video educational intervention to teach patients about cancer, care coordination and self-advocacy will improve patients' perception of care coordination. Cancer patients with early stage disease scheduled to receive adjuvant therapy, and who reside in a rural area, will be enrolled onto the study. Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer knowledge, self-advocacy and care coordination will be obtained at baseline and after 4-6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+ years of age\n* Breast, lung, or colon cancer diagnosis\n* Stage I, II or III cancer\n* Adjuvant chemotherapy started \\< 30 days or planned within the next 30 days\n* Rural residence location in Vermont (outside Chittenden County)\n* Proficient in English\n\nExclusion Criteria:\n\n* History of prior malignancy treated with chemotherapy in last 3 years\n* Known or suspected neuro-cognitive impairment\n* Resident of Chittenden County, Vermont\n* Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer'}, 'identificationModule': {'nctId': 'NCT05723250', 'briefTitle': 'Care Coordination Educational Intervention Study for Patients from Rural Areas with Early Stage Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont Medical Center'}, 'officialTitle': 'Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: a Feasibility Study', 'orgStudyIdInfo': {'id': '00002358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upfront Educational Intervention', 'description': 'Participants will receive a video-based intervention after completing baseline survey instruments and prior to retesting after 4-6 months.', 'interventionNames': ['Other: Table-based Educational Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Educational Intervention', 'description': 'Participants will complete baseline survey instruments and again complete surveys after 4-6 months. They will then receive the video-based educational tablet.', 'interventionNames': ['Other: Table-based Educational Intervention']}], 'interventions': [{'name': 'Table-based Educational Intervention', 'type': 'OTHER', 'otherNames': ['Educational'], 'description': 'Tablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy.', 'armGroupLabels': ['Delayed Educational Intervention', 'Upfront Educational Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Randall F Holcombe', 'role': 'CONTACT'}], 'facility': 'University of Vermont Cancer Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'centralContacts': [{'name': 'Randall F Holcombe', 'role': 'CONTACT', 'email': 'randall.holcombe@med.uvm.edu', 'phone': '18026563812'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Upon request, with removal of PHI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, UVM Cancer Center', 'investigatorFullName': 'Randall F Holcombe', 'investigatorAffiliation': 'University of Vermont Medical Center'}}}}