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

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Cultivando La Salud
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Hispanic women, Behavioral Intervention, Lay Health Workers

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of Puerto Rico, Medical Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cultivando la Salud Educational Intervention

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2020
Last Updated
October 30, 2020
Sponsor
University of Puerto Rico
Collaborators
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04617236
Brief Title
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
Acronym
CLS
Official Title
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2012 (Actual)
Primary Completion Date
September 20, 2013 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Hispanic women, Behavioral Intervention, Lay Health Workers

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Participant
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cultivando la Salud Educational Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey.
Intervention Type
Behavioral
Intervention Name(s)
Cultivando La Salud
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)
Description
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.
Time Frame
4-6 months after the intervention
Title
Number of participants aged 40 and older who completed a mammography test
Description
Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.
Time Frame
4-6 months after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Colón-López, PhD
Organizational Affiliation
Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Puerto Rico, Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00984
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29220062
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.
Results Reference
result
Links:
URL
https://cebp.aacrjournals.org/content/23/11_Supplement/B69
Description
Poster Presentation at the AACR Conference: The Science of Cancer Health Disparities; December 6-9, 2013; Atlanta, GA

Learn more about this trial

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

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