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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426019
• Other study ID #: HSC-SPH-11-0179
• Status: Completed
• Phase: N/A
• Start date: January 12, 2012
• Est. completion date: May 16, 2014

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. completion date: May 16, 2014
• Est. primary completion date: May 16, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• CLS Intervention
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
• No CLS intervention
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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).