Clinical trial NCT01103479: Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Official title: Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Keywords: Early Detection of Cancer
Colorectal Cancer Screening
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-04-14
Enrollment: 569
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

Detailed description: This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

Eligibility criteria: Inclusion Criteria:

* Patients aged 50-75 years of age (in month 1 of the study)
* Patients have had two or more visits to the clinic during the past two years
* ACCESS Community Health Network patients
* University of Illinois Hospital \& Health Sciences System patients
* Patients ages 50 - 75 as of the start of the intervention study
* English or Spanish-Speaking

Exclusion Criteria:

* Patients \<50 or \> 75 years of age
* Patients who have had fewer than two or more visits to the clinic during the past two years
* Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
* Unable to speak English or Spanish
* Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

Primary outcomes:
measure: Colorectal Cancer (CRC) Screening Completion
timeFrame: within 6 months of provider recommendation
measure: Colorectal Cancer (CRC) Screening Completion
timeFrame: within 6 months of provider recommendation
Secondary outcomes:
measure: Provider Recommendation of CRC Screening
timeFrame: 6 months following patient enrollment into study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
Study officials:
affiliation: Northwestern University
name: Kenzie A Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameron KA, Ramirez-Zohfeld V, Ferreira MR, Dolan NC, Radosta J, Galanter WL, Eder MM, Wolf MS, Rademaker AW. The Effects of a Multicomponent Colorectal Cancer Screening Intervention on Knowledge, Recommendation, and Screening among Underserved Populations. J Health Care Poor Underserved. 2020;31(4):1612-1633. doi: 10.1353/hpu.2020.0122.
citation: Ramirez-Zohfeld V, Rademaker AW, Dolan NC, Ferreira MR, Eder MM, Liu D, Wolf MS, Cameron KA. Comparing the Performance of the S-TOFHLA and NVS Among and Between English and Spanish Speakers. J Health Commun. 2015;20(12):1458-64. doi: 10.1080/10810730.2015.1018629. Epub 2015 Jul 6.
citation: Dolan NC, Ramirez-Zohfeld V, Rademaker AW, Ferreira MR, Galanter WL, Radosta J, Eder MM, Cameron KA. The Effectiveness of a Physician-Only and Physician-Patient Intervention on Colorectal Cancer Screening Discussions Between Providers and African American and Latino Patients. J Gen Intern Med. 2015 Dec;30(12):1780-7. doi: 10.1007/s11606-015-3381-8. Epub 2015 May 19.