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

University of Puerto Rico (UPR)

Status: Completed

Conditions: Breast Cancer; Cervical Cancer

Treatments: Behavioral: Cultivando La Salud

Study type: Interventional

Funder types: Other

Identifiers

NCT04617236

A1250312

Details and patient eligibility

About

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).

Full 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

Enrollment: 444 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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444 participants in 2 patient groups

Cultivando la Salud Educational Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cultivando La Salud

Control

No Intervention group

Description:

No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey.