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

The University of Texas System (UT)

Status: Completed

Conditions: Breast Cancer; Cervical Cancer

Treatments: Behavioral: CLS Intervention; Behavioral: No CLS intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04426019

HSC-SPH-11-0179

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,025 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,025 participants in 2 patient groups

CLS intervention

Experimental group

Description:

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.

Treatment:

Behavioral: CLS Intervention

No CLS intervention

Active Comparator group

Description:

Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines.

Treatment:

Behavioral: No CLS intervention