Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06082505
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2023-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of women 40 years and older who complete mammogram screening', 'timeFrame': 'Between baseline and end of study (about 9 months)', 'description': 'Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.'}, {'measure': 'Number of women 21-65 years old who complete Pap test screening', 'timeFrame': 'Between baseline and end of study (about 9 months)', 'description': 'Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.'}, {'measure': 'Number of women 21-26 years old who initiate their HPV vaccination series.', 'timeFrame': 'between baseline and end of study (about 9 months)', 'description': 'Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.'}], 'secondaryOutcomes': [{'measure': 'Number of participants who received the second dose of HPV vaccine', 'timeFrame': 'between baseline and end of study (about 9 months)', 'description': 'Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.'}, {'measure': 'Number of participants who received the third dose of HPV vaccine', 'timeFrame': 'between baseline and end of study (about 9 months)', 'description': 'Among women that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.'}, {'measure': 'Number of participants who received a clinical breast exam', 'timeFrame': 'between baseline and end of study (about 9 months)', 'description': 'Among women that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical cancer prevention', 'Breast cancer detection', 'HPV vaccination'], 'conditions': ['Cervical Cancer', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate implementation of a community-based prevention project aimed at increasing early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.', 'detailedDescription': 'This is an evaluation of the Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination, using a one-group pre-post study design (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self identifies as Hispanic or Latina\n* Lives in Texas\n* Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older\n* Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older\n* HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series\n* Age limit for breast cancer screening group: 40 years and older\n* Age limit for cervical cancer screening group (Pap test): 21 years and older\n* Age limit for HPV vaccination group: 21-26 years\n\nExclusion Criteria:\n\n* Current pregnancy\n* Current or prior cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT06082505', 'acronym': 'SEMM1', 'briefTitle': 'Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.', 'orgStudyIdInfo': {'id': 'HSC-SPH-16-0159'}, 'secondaryIdInfos': [{'id': 'PP160047', 'type': 'OTHER_GRANT', 'domain': 'Cancer Prevention and Research Institute of Texas'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-Person Delivered Breast and Cervical Cancer Behavioral Intervention', 'description': 'Community health worker deliver behavioral education and referrals to low-cost services. Deliver in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.', 'interventionNames': ['Behavioral: Education', 'Behavioral: Navigation to clinic']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone Delivered Breast and Cervical Cancer Behavioral Intervention', 'description': 'Community health worker deliver behavioral education and referrals to low-cost services. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.', 'interventionNames': ['Behavioral: Education', 'Behavioral: Navigation to clinic']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Education will be delivered in person in a group education setting or individually by phone. Group education will include 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).', 'armGroupLabels': ['In-Person Delivered Breast and Cervical Cancer Behavioral Intervention', 'Telephone Delivered Breast and Cervical Cancer Behavioral Intervention']}, {'name': 'Navigation to clinic', 'type': 'BEHAVIORAL', 'description': "Continue telephone based navigation tailored to participants' barriers using the Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.", 'armGroupLabels': ['In-Person Delivered Breast and Cervical Cancer Behavioral Intervention', 'Telephone Delivered Breast and Cervical Cancer Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lara Savas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lara Savas', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}