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Completed

NCT Number: NCT04426019

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLS Intervention

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

Other names: CHW-delivered education

No CLS intervention

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

Other names: Usual Care

Primary outcomes

  1. The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report.

    Time frame: 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

  2. The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Cancer Prevention Research Institute of Texas

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2020
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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