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

NCT ID: NCT04426019

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1025 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-12
• Study Completion Date: 2014-05-16

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.

Conditions

Breast Cancer; Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CLS Intervention

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

No CLS intervention

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Other Intervention Names

CHW-delivered education; Usual Care

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Lara Savas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Savas

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-SPH-11-0179

Identifier Type: -

Identifier Source: org_study_id