Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2026-01-05 @ 6:30 PM
Study NCT ID:
NCT05425992
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Communication and Building a Stronger Medical Home Among Spanish-speaking Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine a baseline level of Spanish speaking patient satisfaction of care', 'timeFrame': '12 months', 'description': 'Understand the patient experience using qualitative interview of Spanish speaking patients and families Determine satisfaction based on open-ended question with unsatisfied to satisfied as markers.'}, {'measure': 'Determine a baseline level of Spanish Speaking family satisfaction of care', 'timeFrame': '12 months', 'description': 'Understand the patient experience using qualitative interview of Spanish speaking patients and families Determine satisfaction based on open-ended question with unsatisfied to satisfied as markers.'}, {'measure': 'Determine effects of language barrier on Spanish speaking patient needs', 'timeFrame': '12 months', 'description': 'Understand the patient experience using qualitative interview of Spanish speaking patients and families.\n\nDetermine satisfaction based on open-ended question to determine a list or pattern of common patient needs.'}, {'measure': 'Determine the effect of language barrier on barriers to patient care', 'timeFrame': '12 months', 'description': 'Understand the patient experience using qualitative interview of Spanish speaking patients and families.\n\nDetermine satisfaction based on open-ended question to determine a list or pattern of common barriers to patient care.'}, {'measure': 'Effect of language barrier on efficiency of access to care', 'timeFrame': '12 months', 'description': 'Understand the patient experience using qualitative interview of Spanish speaking patients and families.\n\nDetermine satisfaction based on open-ended question to determine how quickly patient was able to receive care.'}], 'secondaryOutcomes': [{'measure': 'Determine patient interest in home telemedicine support program', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedicine support program.'}, {'measure': 'Determine patient interest in home telemedicine support program after discharge', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedicine support program to be used after discharge from hospital.'}, {'measure': 'Determine Spanish speaking patient interest in telemedical check-ins during intensive phases of therapy', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedical support during treatment.'}, {'measure': 'Determine Spanish speaking patient interest in medication assistance during intensive phases of therapy', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedical medication support during therapy.'}, {'measure': 'Determine Spanish speaking patient interest in medical check-ins during maintenance', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedical check-ins during maintenance.'}, {'measure': 'Determine Spanish speaking patient interest in medication assistance during maintenance', 'timeFrame': '12 months', 'description': 'Open-ended questions will be used to determine level of interest in a telemedical medication assistance during maintenance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spanish-speaking'], 'conditions': ['Leukemia', 'Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study will seek to improve communication with Spanish speaking families and patients with Cancer and Blood Disorders.', 'detailedDescription': 'The Principal Investigator seeks to improve communication with Spanish speaking families with the following goals: 1) to increase patient and family sense of inclusion in the medical community, 2) to increase patient and family medical knowledge and understanding, 3) to improve patient adherence with critical medical regimens, and ultimately, 4) to increase equality of comprehensive medical care delivery across the continuum of care including physical and psychosocial domains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for enrollment are identified from EPIC electronic medical record with notification for newly diagnosed families of Spanish language preference.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 22 years of age\n* Diagnosis of leukemia or non-Hodgkin lymphoma\n* Spanish as preferred language for patient, parent or guardian\n* Received or receiving care at the Center for Cancer and Blood Disorders (CCBD)\n\nExclusion Criteria:\n\n* Patients without oncologic diagnosis\n* Patients with parents whose language preference is English\n* Patients who received care solely outside of the CCBD'}, 'identificationModule': {'nctId': 'NCT05425992', 'briefTitle': 'Improving Communication and Building a Stronger Medical Home Among Spanish-speaking Families', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Improving Communication with and Building a Stronger Medical Home Among Spanish-speaking Families in the Center for Cancer and Blood Disorders', 'orgStudyIdInfo': {'id': '21-4238.cc'}, 'secondaryIdInfos': [{'id': 'NCI-2022-04061', 'type': 'OTHER', 'domain': 'CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated in CCBD', 'description': 'Patients who are currently receiving therapy at the Center for Cancer and Blood Disorders', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Patient/parent dyads expressing interest will be interviewed by a bilingual Spanish certified provider via televideo with as needed interpreter support. Interviews will be audio recorded for review and translation purposes and then will be destroyed. Interview format will be supportive and information seeking only with reassurance that purpose is for care improvement and that all answers will be evaluated without association to patient name. Interviews will then be translated and reviewed by the PI for themes regarding perceived clinic successes and perceived clinic barriers in communication or care.', 'armGroupLabels': ['Patients treated in CCBD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wendy Moore', 'role': 'CONTACT', 'email': 'wendy.moore@childrenscolorado.org', 'phone': '1-720-777-6353'}, {'name': 'Ashley Rogers', 'role': 'CONTACT'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Wendy Moore', 'role': 'CONTACT', 'email': 'wendy.moore@childrenscolorado.org', 'phone': '1-720-777-6353'}], 'overallOfficials': [{'name': 'Ashley Rogers', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Colorado", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}