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

¡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: Colorectal Cancer
• Intervention / Treatment: Behavioral: ¡Salud! Por la Vida

• Study Type: Interventional
• Enrollment (Actual): 445
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• 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

General Publications

• 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.
• 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. 2022 Mar 31. doi: 10.1007/s13187-022-02153-z. Online ahead of print.

Helpful Links

• ¡Salud! por la Vida Educational Materials in Spanish
• ¡Salud! por la Vida Educational Materials in English

Study record dates

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: Colorectal cancer; Colonoscopy; Behavioral Intervention; Colorectal cancer screening; Hispanic/Latino; cancer prevention; Lay Health Workers
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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