Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

NCT ID: NCT01103479

Last Updated: 2015-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

569 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Participants will complete interviewer-administered pre- and post-test

Group Type NO_INTERVENTION

No interventions assigned to this group

Physician Intervention

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Group Type EXPERIMENTAL

Physician Intervention

Intervention Type BEHAVIORAL

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

Physician and Patient Intervention

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Group Type EXPERIMENTAL

Physician and Patient Intervention

Intervention Type BEHAVIORAL

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

Interventions

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Physician Intervention

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

Intervention Type BEHAVIORAL

Physician and Patient Intervention

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Kenzie Cameron

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenzie A Cameron, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Access Community Health Network

Chicago, Illinois, United States

Site Status

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33416742 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26147770 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25986137 (View on PubMed)

Other Identifiers

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R01CA140177

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA140177-01

Identifier Type: NIH

Identifier Source: org_study_id

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