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

Not Applicable

Completed

• Conditions: Breast Cancer; Cervical Cancer
• Interventions: Behavioral: CLS Intervention; Behavioral: No CLS intervention

• Registration Number: NCT04426019
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01-12
• Primary Completion: 2014-05-16
• Study Completion: 2014-05-16
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1025

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLS intervention	CLS Intervention	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.
No CLS intervention	No CLS intervention	Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States