Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-27 @ 5:56 AM
Study NCT ID:
NCT05162404
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2021-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Education to Improve Rural Cancer Care Delivery
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in rural patients' perceptions of cancer care coordination as assessed by the Care Coordination Instrument at 4-6 months post-intervention.", 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Rural patient satisfaction with video education materials as assessed by semi-structured telephone interview.', 'timeFrame': '6 months'}, {'measure': "To examine patient demographic and clinical information collected from the background questionnaire as potential correlates of patients' perceptions of cancer care coordination at post-intervention", 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '39636502', 'type': 'DERIVED', 'citation': 'Okado I, Braun-Inglis C, Matsumoto K, Elhajj C, Cassel K, Berenberg J, Holcombe RF. Feasibility of a Remote Patient Video Education Intervention to Improve Care Coordination for Rural Cancer Patients. J Cancer Educ. 2025 Aug;40(4):594-599. doi: 10.1007/s13187-024-02550-6. Epub 2024 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand if a video-based education program delivered on a tablet device will improve care coordination experiences for patients with cancer living in rural areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a newly diagnosed Stage I, II, or III disease at the time of enrollment.\n* Patients to be treated with adjuvant chemotherapy or recent initiation of (within 1 month of starting) adjuvant chemotherapy.\n* Patients with a history of previous malignancy treated with chemotherapy within the last 3 years are not eligible, as their perceptions of care coordination may be impacted by their previous treatment.\n* Patients must be ≥ 18 years of age.\n* Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.\n* Patients must be residents of Hawaii, Kauai, or Maui counties\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.'}, 'identificationModule': {'nctId': 'NCT05162404', 'briefTitle': 'Video Education to Improve Rural Cancer Care Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery', 'orgStudyIdInfo': {'id': 'Okado 2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Intervention', 'description': 'The intervention in this study is a TED-talk style video series designed to provide patient education on cancer, care coordination, and self-advocacy. The content is designed to provide both a background about cancer disease and to address each of the specific domains in care coordination (CCI). The development of video contents was informed by our prior/current research in rural care coordination and components of evidence-based interventions including the patient navigator training by the George Washington University Cancer Institute, Imi Hale (the Native Hawaiian Cancer Network), and a supportive care intervention by Mokuau et al. As the target population of this intervention is rural patients, videos include some rural-specific considerations related to care coordination.', 'interventionNames': ['Behavioral: Video Education Program']}], 'interventions': [{'name': 'Video Education Program', 'type': 'BEHAVIORAL', 'description': 'The following topics are addressed in each module of the videos:\n\n1. Understanding cancer and cancer treatment - including an understanding of stage, site of origin, metastases, treatment options, toxicities and anticipated outcomes.\n2. Care coordination basics (CC: Communication) - including navigating care related to appointments, how to handle issues after-hours, and the expected roles of other healthcare providers (e.g., PCPs).\n3. How to be a self-advocate (CC: Navigation and Operational) - including how to ask questions, being empowered to talk to your doctor, when a second opinion is needed, when to explore clinical trials, and how to best incorporate a caregiver into your treatment.', 'armGroupLabels': ['Video Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'University of Hawaii Cancer Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hope Foundation for Cancer Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}