Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2
NCT ID: NCT06082882
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
8000 participants
INTERVENTIONAL
2020-02-20
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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In-Person Delivered Breast and Cervical Cancer Behavioral Intervention
Community health worker delivered behavioral education and referrals to low-cost services. Delivered 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.
Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include a \~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
Telephone Delivered Breast and Cervical Cancer Behavioral Intervention
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include a \~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
Zoom Delivered Breast and Cervical Cancer Behavioral Intervention
Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.
Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include a \~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
Interventions
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Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include a \~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.
Eligibility Criteria
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Inclusion Criteria
* Women 40 years of age and older with no mammogram in the past 2 years
* Women 21-65 years, with no Pap test in the past 3 years
* Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.
Exclusion Criteria
* Have a current or prior cancer diagnosis
18 Years
74 Years
FEMALE
Yes
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Lara Savas
Associate Professor
Principal Investigators
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Lara Savas, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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PP190061
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC-SPH-19-0775
Identifier Type: -
Identifier Source: org_study_id