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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer, Cervical Cancer

Intervention / Treatment
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* Behavioral: Cultivando La Salud


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A randomized controlled trial using a pre-post comparison group design. Eligibility criteria included ages 21 and older for the Pap cohort and 40 and older for the mammography cohort, non-adherence to recommended Pap test screening and/or mammography screening guidelines according to the American Cancer Society, no hysterectomy, no diagnosis of cancer, and not currently pregnant. Trained data collectors administered a baseline survey to eligible women and randomly assigned them to the intervention or to a comparison condition. Lay Health Workers delivered the intervention in women's homes, and administered the follow-up survey by phone 4 to 6 months following baseline.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cultivando la Salud Educational Intervention<br>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<br>* 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).<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants aged 21 and older who completed a cervical cancer screening (Pap test) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic women, Behavioral Intervention, Lay Health Workers