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

Not Applicable

Completed

• Conditions: Cervical Cancer; Breast Cancer
• Interventions: Behavioral: Cultivando La Salud

• Registration Number: NCT04617236
• Lead Sponsor: University of Puerto Rico

Brief Summary

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).

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 Timeline

• Study Start: 2012-05-15
• Primary Completion: 2013-09-20
• Study Completion: 2020-07-02
• Status Verified: 2020-10
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-30
• Last Update Submitted: 2020-10-30
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 444

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cultivando la Salud Educational Intervention	Cultivando La Salud	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.

Primary Outcome Measures

Name	Time	Method
Number of participants aged 40 and older who completed a mammography test	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.
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)	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.

Trial Locations

Locations (1)

University of Puerto Rico, Medical Sciences Campus; 🇵🇷 San Juan, Puerto Rico