Clinical trial NCT04426019: Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women
Official title: Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Keywords: Mammogram
Pap test
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2020-06-11
Enrollment: 1025
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report.
timeFrame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
measure: The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report.
timeFrame: end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lara Savas
role: PRINCIPAL_INVESTIGATOR
References: