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Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unidas por Vida y Salud prevention program
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 - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • overdue for a repeat mammogram
  • overdue for repeat cervical screening

Exclusion Criteria:

-

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Unidas por Vida y Salud prevention program

No intervention control

Arm Description

Unidas por Vida y Salud (United for Life and Health) prevention program

The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed).

Outcomes

Primary Outcome Measures

Number of participants who uptake clinical breast exam (CBE)
Number of participants who uptake mammography
Number of participants who uptake pap test
Number of participants who repeat mammography
Number of participants who repeat pap test

Secondary Outcome Measures

Full Information

First Posted
May 17, 2020
Last Updated
May 17, 2020
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
NCT04397744
Brief Title
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
Official Title
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2015 (Actual)
Primary Completion Date
October 17, 2017 (Actual)
Study Completion Date
October 17, 2017 (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 purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.

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
Non-Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unidas por Vida y Salud prevention program
Arm Type
Experimental
Arm Description
Unidas por Vida y Salud (United for Life and Health) prevention program
Arm Title
No intervention control
Arm Type
No Intervention
Arm Description
The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed).
Intervention Type
Behavioral
Intervention Name(s)
Unidas por Vida y Salud prevention program
Intervention Description
The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.
Primary Outcome Measure Information:
Title
Number of participants who uptake clinical breast exam (CBE)
Time Frame
6 months
Title
Number of participants who uptake mammography
Time Frame
6 months
Title
Number of participants who uptake pap test
Time Frame
6 months
Title
Number of participants who repeat mammography
Time Frame
6 months
Title
Number of participants who repeat pap test
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: overdue for a repeat mammogram overdue for repeat cervical screening Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez
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

Citations:
PubMed Identifier
33548363
Citation
Savas LS, Atkinson JS, Figueroa-Solis E, Valdes A, Morales P, Castle PE, Fernandez ME. A lay health worker intervention to improve breast and cervical cancer screening among Latinas in El Paso, Texas: A randomized control trial. Prev Med. 2021 Apr;145:106446. doi: 10.1016/j.ypmed.2021.106446. Epub 2021 Feb 4.
Results Reference
derived

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Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso

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