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

Breast Cancer Clinical Trial

— CLS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617236
• Other study ID #: A1250312
• Status: Completed
• Phase: N/A
• Start date: May 15, 2012
• Est. completion date: July 2, 2020

Study information

• Verified date: October 2020
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: July 2, 2020
• Est. primary completion date: September 20, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Cultivando La Salud
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).

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (1)

Colón-López V, González D, Vélez C, Fernández-Espada N, Feldman-Soler A, Ayala-Escobar K, Ayala-Marín AM, Soto-Salgado M, Calo WA, Pattatucci-Aragón A, Rivera-Díaz M, Fernández ME. Community-Academic Partnership to Implement a Breast and Cervical Cancer S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Poster Presentation at the AACR Conference: The Science of Cancer Health Disparities; December 6-9, 2013; Atlanta, GA