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

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLS Intervention
No CLS intervention
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Mammogram, Pap test

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CLS intervention

No CLS intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 27, 2020
Last Updated
October 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT04426019
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2012 (Actual)
Primary Completion Date
May 16, 2014 (Actual)
Study Completion Date
May 16, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Mammogram, Pap test

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1025 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLS intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No CLS intervention
Arm Type
Active Comparator
Arm Description
Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines.
Intervention Type
Behavioral
Intervention Name(s)
CLS Intervention
Other Intervention Name(s)
CHW-delivered education
Intervention Description
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
Intervention Name(s)
No CLS intervention
Other Intervention Name(s)
Usual Care
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary outcome for breast cancer screening outcome based on mammography screening behavior measured among participants using self-report.
Description
Outcomes based on self-report on follow-up survey
Time Frame
end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).
Title
The primary outcome for cervical cancer screening outcome based on Pap screening behavior measured among participants using self-report.
Description
Outcomes based on self-report on follow-up survey
Time Frame
end of evaluation period (6 month follow-up survey, through completion of hard to follow-up period on average 10 months).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Savas
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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