Clinical trial NCT04617236: Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
Official title: Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Keywords: Hispanic women
Behavioral Intervention
Lay Health Workers
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2020-11-05
Enrollment: 444
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)
timeFrame: 4-6 months after the intervention
measure: Number of participants aged 40 and older who completed a mammography test
timeFrame: 4-6 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
affiliation: Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus
name: Vivian Colón-López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colon-Lopez V, Gonzalez D, Velez C, Fernandez-Espada N, Feldman-Soler A, Ayala-Escobar K, Ayala-Marin AM, Soto-Salgado M, Calo WA, Pattatucci-Aragon A, Rivera-Diaz M, Fernandez ME. Community-Academic Partnership to Implement a Breast and Cervical Cancer Screening Education Program in Puerto Rico. P R Health Sci J. 2017 Dec;36(4):191-197.