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

NCT ID: NCT04617236

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-15

Study Completion Date

2020-07-02

Brief Summary

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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

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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

Conditions

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Breast Cancer Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Cultivando la Salud Educational Intervention

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.

Group Type EXPERIMENTAL

Cultivando La Salud

Intervention Type 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).

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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Vivian Colon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivian Colón-López, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Puerto Rico, Medical Sciences Campus

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

References

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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.

Reference Type RESULT
PMID: 29220062 (View on PubMed)

Other Identifiers

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A1250312

Identifier Type: -

Identifier Source: org_study_id