Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1

NCT ID: NCT06082505

Last Updated: 2023-12-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-05-29

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cervical Cancer Breast Cancer

Keywords

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Cervical cancer prevention Breast cancer detection HPV vaccination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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In-Person Delivered Breast and Cervical Cancer Behavioral Intervention

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.

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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).

Navigation to clinic

Intervention Type BEHAVIORAL

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.

Telephone Delivered Breast and Cervical Cancer Behavioral Intervention

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.

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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).

Navigation to clinic

Intervention Type BEHAVIORAL

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.

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 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).

Intervention Type BEHAVIORAL

Navigation to clinic

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self identifies as Hispanic or Latina
* Lives in Texas
* Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
* Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
* HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
* Age limit for breast cancer screening group: 40 years and older
* Age limit for cervical cancer screening group (Pap test): 21 years and older
* Age limit for HPV vaccination group: 21-26 years

Exclusion Criteria

* Current pregnancy
* Current or prior cancer diagnosis
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Lara Savas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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PP160047

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-SPH-16-0159

Identifier Type: -

Identifier Source: org_study_id