¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program (SPLV)

August 15, 2022 updated by: Vivian Colon, University of Puerto Rico

¡Salud! Por la Vida: A Colorectal Screening Promotion Program for Patients Attending Federally Qualified Health Centers in Puerto Rico.

The overall goal of this educational program was to increase colorectal cancer screening (CRCS) in men and women who attend Federally Qualified Health Centers (FQHC) in Puerto Rico. FQHCs, referred to in Puerto Rico as "Clínicas 330", are ideal settings to implement innovative approaches to increase CRCS because they serve primarily low-income patients who typically have lower rates of screening. The goal of this study, is to develop and evaluate the impact of a clinic level intervention on increasing CRCS among low-income Puerto Rican men and women aged 50-75, who have either never been screened for colorectal cancer, or are under-screened according recommended guidelines. To evaluate the delivery of the CRCS education program we used a group randomized controlled trial that provided data to determine the effectiveness of the CRC intervention program compared with usual practice (no intervention).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00984
        • University of Puerto Rico, Medical Sciences Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female aged 50-75, patient at a participating FQHC.
  • Male aged 50-75, patient at a participating FQHC.

Exclusion Criteria:

  • Having completed a fecal occult blood test (FOBT) or a fecal immunochemical test (FIT) in the past year.
  • Having completed a sigmoidoscopy in the last 5 years.
  • Having completed a colonoscopy in the last 10 years.
  • Prior history of colorectal cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Intervention Arm: ¡Salud! Por la vida Educational Intervention After completing eligibility and baseline surveys, trained lay health workers delivered an educational intervention for colorectal cancer screening with included a tailored interactive multimedia intervention (TIMI), newsletter, infographics, and a provider prompt for colorectal cancer screening. This educational session was delivered at intervention clinics and lasted about 1 hour. Follow-up data was collected starting at 6 months post educational session.
Behavioral: ¡Salud! Por la Vida
Lay health worker (LHW) delivered educational intervention for colorectal cancer screening (CRCS). The intervention consisted in having the participant complete a tailored interactive multimedia intervention (TIMI). TIMI consisted of a series of educational videos that addressed common barriers to colorectal cancer screening as well as provided information about colorectal cancer (CRC) and CRCS tests. Participants were able to tailor the TIMI for sex (male/female) and CRC family history. After TIMI completion, the LHW provided participant with a copy of the SPLV newsletter and printed infographics on CRC, CRCS, and an action plan tailored by type of CRCS (FOBT/FIT or colonoscopy). The Intervention Group subject participation took approx. up to 2 hours and Control Group up to 1 hour (half hour for each: baseline and follow-up interview). Follow-up data was collected 6 months post education session (intervention group) or post-baseline survey (control group).
No Intervention: Control Arm
Control Arm: No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 6 months post-baseline survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal Cancer Screening
Time Frame: 6 months after the intervention
Number of participants aged 50-75 who completed a colorectal cancer screening (FOBT, FIT, and/or colonoscopy) Screening behavior status at follow-up was assessed by asking patients the month and year of their last CRCS and by medical record review.
6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2017

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8060116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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