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OpenTrials
Completed

NCT Number: NCT01103479

Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Access Community Health Network, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physician Intervention

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

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

Primary outcomes

  1. Colorectal Cancer (CRC) Screening Completion

    Time frame: within 6 months of provider recommendation

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

  2. Colorectal Cancer (CRC) Screening Completion

    Time frame: within 6 months of provider recommendation

    CRC screening completion via FOBT, FIT or Colonoscopy

Secondary outcomes

  1. Provider Recommendation of CRC Screening

    Time frame: 6 months following patient enrollment into study

    Provider recommendation of CRC Screening based on chart review

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2010
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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