Clinical trial NCT05502666: ¡Salud! Por la Vida (SPLV) A Colorectal Screening Promotion Program
Official title: ¡Salud! Por la Vida: A Colorectal Screening Promotion Program for Patients Attending Federally Qualified Health Centers in Puerto Rico.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Hispanic/Latino
Behavioral Intervention
Lay Health Workers
Colorectal cancer
Colorectal cancer screening
Colonoscopy
cancer prevention
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: M.D. Anderson Cancer Center
name: National Cancer Institute (NCI)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-16
Enrollment: 445
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Colorectal Cancer Screening
timeFrame: 6 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
References:
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.
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.