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

Colorectal Cancer Clinical Trial

— SPLV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502666
• Other study ID #: A8060116
• Status: Completed
• Phase: N/A
• Start date: July 8, 2017
• Est. completion date: July 2, 2020

Study information

• Verified date: August 2022
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan

Sponsors (5)

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

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (2)

Colón-López V, Valencia-Torres IM, Ríos EI, Llavona J, Vélez-Álamo C, Fernández 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. [Epub ahead of print] — View Citation

Serra YA, Colón-López V, Savas LS, Vernon SW, Fernández-Espada N, Vélez C, Ayala A, Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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