Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women
Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston
1 other identifier
interventional
1,025
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2014
CompletedFirst Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedOctober 12, 2023
October 1, 2023
2.3 years
May 27, 2020
October 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
Study Arms (2)
CLS intervention
EXPERIMENTALCommunity 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
ACTIVE COMPARATORCommunity health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women, and women who are adherent to screening guidelines
- prior or current cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Savas
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 11, 2020
Study Start
January 12, 2012
Primary Completion
May 16, 2014
Study Completion
May 16, 2014
Last Updated
October 12, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share