Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-02 @ 9:27 PM
Study NCT ID:
NCT06492993
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-19
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003638', 'term': 'Deafness'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who are adherent to cancer screening', 'timeFrame': '9 months', 'description': 'Completion of at least one recommended cancer screening as measured by documentation of the actual screening'}], 'secondaryOutcomes': [{'measure': 'Percent of participants who demonstrate high cancer knowledge and high perceived patient centered care', 'timeFrame': '9 months', 'description': 'Positive change in patient-physician communication and cancer knowledge from baseline to closeout as defined by the participating patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Deafness']}, 'referencesModule': {'references': [{'pmid': '40925603', 'type': 'DERIVED', 'citation': 'Kushalnagar P, Rao SR, Bergeron E, Valdez R, Wang R, Kushalnagar RS, Sadler GR. Using American Sign Language-Fluent Community Health Navigators to Advance Cancer Screening Adherence through Videoconferencing With Deaf, Deafblind, and Hard of Hearing Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 9;14:e65078. doi: 10.2196/65078.'}]}, 'descriptionModule': {'briefSummary': 'Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.', 'detailedDescription': 'Study hypothesizes that the intervention that involves utilization of a DDBHH CHN will result in (i) DDBHH patients demonstrating greater adherence to screening compared to DDBHH patients who were assigned to the standard of care group , and (ii) higher patient-physician communication rating by DDBHH patients compared to DDBHH patients who were assigned to the standard of care group. Bilingual ASL-English measures (e.g., sociodemographics, cancer knowledge, patient-physician communication) will be administered to the participant at baseline data collection and again after the final data collection or by 11 months for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n\nStated willingness to comply with all study procedures and lifestyle considerations (see Section 5.3, Lifestyle Considerations) and availability for the duration of the study\n\nMale or female at birth age 45-80yo or female at birth age 45-80yo; age-eligible according to screening criteria\n\nSelf-reported diagnosis of bilateral hearing loss at birth or prior to 13 years old (defined as "early deafness") and use ASL\n\nWillingness to adhere to the CHN clinical trial regimen\n\nWillingness to provide cancer screening verification documentation; this will be reviewed during the informed consent procedure\n\nAccess to necessary resources to support video-based communication\n\nNon-adherent to one or more cancer screening guidelines for breast, lung, prostate, colon, cervical cancers will be those who reported not having had the appropriate recommended screenings within the past year to cancer screening questions in the HINTS-ASL survey\n\nExclusion Criteria:\n\n* Presence of full ability to hear in one or both ears beyond 13 years of age\n\nYounger or older than the age cutoff for the recommended cancer screening\n\nNot capable of independently conducting the activities of daily living\n\nIn compliance with age- or risk-specific screening at the time of evaluation for study eligibility\n\nAre currently undergoing cancer treatment or being evaluated for the presence of cancer at the time of evaluation for study eligibility\n\nWill be engaged in more than 21 consecutive days of travel during the eleven-month study window\n\nKnows other participants at baseline'}, 'identificationModule': {'nctId': 'NCT06492993', 'briefTitle': 'Community Health Navigator Program to Promote Cancer Screenings Among DDBHH People', 'organization': {'class': 'OTHER', 'fullName': 'Gallaudet University'}, 'officialTitle': 'Community Health Navigator Program to Promote Cancer Screenings Among Deaf, Deafblind, and Hard of Hearing Adults Who Use American Sign Language', 'orgStudyIdInfo': {'id': 'CDHE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'CHN provides educational sessions with patients at time points.', 'interventionNames': ['Other: Education']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard of care to inform participant about the screening recommendations and check ins.'}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'description': 'The CHN meets with DDBHH participant over sessions to provide navigation support through the cancer screening process.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20002', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Gallaudet University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Poorna Kushalnagar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gallaudet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gallaudet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}