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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Physician Intervention
Physician and Patient Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Early Detection of Cancer, Colorectal Cancer Screening

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Access Community Health Network
  • University of Illinois Hospital & Health Sciences System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Physician Intervention

Physician and Patient Intervention

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Colorectal Cancer (CRC) Screening Completion
CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Colorectal Cancer (CRC) Screening Completion
CRC screening completion via FOBT, FIT or Colonoscopy

Secondary Outcome Measures

Provider Recommendation of CRC Screening
Provider recommendation of CRC Screening based on chart review

Full Information

First Posted
April 12, 2010
Last Updated
April 14, 2015
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01103479
Brief Title
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Official Title
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Early Detection of Cancer, Colorectal Cancer Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will complete interviewer-administered pre- and post-test
Arm Title
Physician Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Physician and Patient Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Physician Intervention
Intervention Description
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
Intervention Name(s)
Physician and Patient Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Colorectal Cancer (CRC) Screening Completion
Description
CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Time Frame
within 6 months of provider recommendation
Title
Colorectal Cancer (CRC) Screening Completion
Description
CRC screening completion via FOBT, FIT or Colonoscopy
Time Frame
within 6 months of provider recommendation
Secondary Outcome Measure Information:
Title
Provider Recommendation of CRC Screening
Description
Provider recommendation of CRC Screening based on chart review
Time Frame
6 months following patient enrollment into study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenzie A Cameron, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Access Community Health Network
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States
Facility Name
University of Illinois Hospital & Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33416742
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.
Results Reference
derived
PubMed Identifier
26147770
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.
Results Reference
derived
PubMed Identifier
25986137
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.
Results Reference
derived

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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

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