Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women (CLS)

October 30, 2020 updated by: Vivian Colon, University of Puerto Rico
The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in Canóvanas, Puerto Rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. To evaluate promotoras' delivery of the CLS screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the CLS intervention program compared with usual practice (no intervention).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed promotora and community based breast and cervical screening education program includes the following specific aims:

Aim 1. To train community health workers (promotoras) from Taller Salud to implement the CLS breast and cervical cancer screening program. Taller Salud staff train and build capacity of promotoras to implement the CLS community-based education and navigation program.

Aim 2. To deliver the CLS intervention program to at least 600 women in Canóvanas municipality, Puerto Rico.

Aim 3. To evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in Canóvanas, Puerto Rico.

Aim 4. To adapt and update intervention materials

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00984
        • University of Puerto Rico, Medical Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 21 and older for Pap cohort
  • Women aged 40 and older for Mammography cohort

Exclusion Criteria:

  • Having completed a Papanicolau test in the past 3 years if participant is between the ages of 21-65.
  • Having completed a Mammography screening in the past year if participant is aged 40 or older
  • Have a hysterectomy
  • Currently pregnant
  • History of any type of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cultivando la Salud Educational Intervention
After completing eligibility and baseline surveys, Lay health workers delivered an educational intervention for breast and cervical cancer screening. This educational session was delivered in participants' home and lasted between 1-2 hours. Follow-up data was collected 4-6 months post educational session.
Behavioral: Cultivando La Salud

A lay health worker delivered educational intervention for breast and cervical cancer screening.

In total, the Intervention Group subject participation will take approx. up to four hours (1 hour for interview, 1 hour for the second interview, and 1-2 hours for the CLS intervention) and Control Group up to four hours (One hour for interview, one hour for the second interview, up to two hours for educational intervention after the second interview).

Follow-up data was collected 4-6 months post education session (intervention group) or post-baseline survey (control group).
No Intervention: Control
No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)
Time Frame: 4-6 months after the intervention
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.
4-6 months after the intervention
Number of participants aged 40 and older who completed a mammography test
Time Frame: 4-6 months after the intervention
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.
4-6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Collaborators

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Vivian Colón-López, PhD, Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2012

Primary Completion (Actual)

September 20, 2013

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1250312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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