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

Sponsor

University of Puerto Rico (Other)

Overall Status

Completed

CT.gov ID

NCT05502666

Collaborator

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

445

Enrollment

Location

Arms

35.8

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: ¡Salud! Por la Vida	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

445 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 8, 2017

Actual Primary Completion Date :

Jul 2, 2020

Actual Study Completion Date :

Jul 2, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Colorectal Cancer Screening [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.