NCT04397744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

May 17, 2020

Last Update Submit

May 17, 2020

Conditions

Keywords

MammogramPap test

Outcome Measures

Primary Outcomes (5)

  • Number of participants who uptake clinical breast exam (CBE)

    6 months

  • Number of participants who uptake mammography

    6 months

  • Number of participants who uptake pap test

    6 months

  • Number of participants who repeat mammography

    6 months

  • Number of participants who repeat pap test

    6 months

Study Arms (2)

Unidas por Vida y Salud prevention program

EXPERIMENTAL

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

Behavioral: Unidas por Vida y Salud prevention program

No intervention control

NO INTERVENTION

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).

Interventions

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.

Unidas por Vida y Salud prevention program

Eligibility Criteria

Age21 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Maria E Fernandez

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 21, 2020

Study Start

January 16, 2015

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations