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Completed

NCT Number: NCT04617236

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

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).

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico, Medical Sciences Campus

San Juan, 00984, Puerto Rico

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Number of participants aged 21 and older who completed a cervical cancer screening (Pap test)

    Time frame: 4-6 months after the intervention

    Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.

  2. Number of participants aged 40 and older who completed a mammography test

    Time frame: 4-6 months after the intervention

    Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Acronym: CLS

Important dates

Study start
2012
Primary completion
2013
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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