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

NCT04617236 | Completed

• 1 other identifier: A1250312
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Cervical Cancer

Keywords

Hispanic women; Behavioral Intervention; Lay Health Workers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cultivando la Salud Educational Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Cultivando La Salud BEHAVIORAL

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).

Cultivando la Salud Educational Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 21 and older for Pap cohort
• Women aged 40 and older for Mammography cohort

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Puerto Rico: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Puerto Rico, Medical Sciences Campus

San Juan, 00984, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 29220062 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Vivian Colón-López, PhD

  Graduate School of Public Health, University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: November 5, 2020
• Study Start: May 15, 2012
• Primary Completion: September 20, 2013
• Study Completion: July 2, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)