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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
¡Salud! Por la Vida
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Hispanic/Latino, Behavioral Intervention, Lay Health Workers, Colorectal cancer, Colorectal cancer screening, Colonoscopy, cancer prevention

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Puerto Rico, Medical Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Colorectal Cancer Screening
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.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
August 15, 2022
Sponsor
University of Puerto Rico
Collaborators
The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05502666
Brief Title
¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program
Acronym
SPLV
Official Title
¡Salud! Por la Vida: A Colorectal Screening Promotion Program for Patients Attending Federally Qualified Health Centers in Puerto Rico.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Hispanic/Latino, Behavioral Intervention, Lay Health Workers, Colorectal cancer, Colorectal cancer screening, Colonoscopy, cancer prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Control Arm: No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 6 months post-baseline survey.
Intervention Type
Behavioral
Intervention Name(s)
¡Salud! Por la Vida
Intervention Description
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).
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening
Description
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.
Time Frame
6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Puerto Rico, Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00984
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29270400
Citation
Serra YA, Colon-Lopez V, Savas LS, Vernon SW, Fernandez-Espada N, Velez C, Ayala A, Fernandez ME. Using Intervention Mapping to Develop Health Education Components to Increase Colorectal Cancer Screening in Puerto Rico. Front Public Health. 2017 Dec 7;5:324. doi: 10.3389/fpubh.2017.00324. eCollection 2017.
Results Reference
background
PubMed Identifier
35359256
Citation
Colon-Lopez V, Valencia-Torres IM, Rios EI, Llavona J, Velez-Alamo C, Fernandez ME. Knowledge, Attitudes, and Beliefs About Colorectal Cancer Screening in Puerto Rico. J Cancer Educ. 2023 Apr;38(2):552-561. doi: 10.1007/s13187-022-02153-z. Epub 2022 Mar 31.
Results Reference
background
Links:
URL
https://canceroutreachpr.org/salud-por-la-vida/
Description
¡Salud! por la Vida Educational Materials in Spanish
URL
https://sph.uth.edu/research/centers/chppr/research/puerto-rico/index.htm
Description
¡Salud! por la Vida Educational Materials in English

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

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