Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women

Study Overview
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Brief Summary
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The primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.

Detailed Description
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CHWs identify women in the community in need of breast and/or cervical cancer screening. Based on their screening needs, they invite women to participate in the CLS behavioral intervention. Women are randomized to intervention and usual care comparison (delayed intervention) groups. After women are consented to participate in the study, the study team administers the baseline survey. After the baseline survey is administered, the CLS-adapted intervention (renamed Salud en Mis Manos), is delivered to participants randomized to the intervention group. After the follow-up survey is administered to the participants, women in the comparison group are offered the CLS (SEMM) intervention.

Official Title
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Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston

Conditions
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Breast Cancer, Cervical Cancer

Intervention / Treatment
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* Behavioral: CLS Intervention
* Behavioral: No CLS intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women who identify as Hispanic/Latina ancestry or descent and live in the Greater Houston Area in Texas no previous diagnosis of breast or cervical cancer Exclusion Criteria: Pregnant women, and women who are adherent to screening guidelines prior or current cancer diagnosis

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS intervention<br>Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver behavioral education designed to increase breast and/or cervical cancer screening. After completing the education, CHWs provide women with clinic referrals to local and affordable screening services. Participants also are offered telephone-delivered navigation support, which focuses on helping women overcome logistic and personal barriers to accessing screening services. | Behavioral: CLS Intervention<br>* Community health workers (or promotoras) will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening<br>* Other names: CHW-delivered education;|
| Active Comparator: No CLS intervention<br>Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines. | Behavioral: No CLS intervention<br>* This control arm will receive only usual practice care (print education) and will not receive the CLS intervention. They may receive the intervention after the study has been completed<br>* Other names: Usual Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report. | Outcomes based on self-report on follow-up survey | end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months). | 
| The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report. | Outcomes based on self-report on follow-up survey | end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammogram, Pap test