NCT01103479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
569

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 9, 2014

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

April 12, 2010

Results QC Date

August 28, 2014

Last Update Submit

April 14, 2015

Conditions

Colorectal Cancer

Keywords

Early Detection of CancerColorectal Cancer Screening

Outcome Measures

Primary Outcomes (2)

  • Colorectal Cancer (CRC) Screening Completion

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

    within 6 months of provider recommendation

  • Colorectal Cancer (CRC) Screening Completion

    CRC screening completion via FOBT, FIT or Colonoscopy

    within 6 months of provider recommendation

Secondary Outcomes (1)

  • Provider Recommendation of CRC Screening

    6 months following patient enrollment into study

Study Arms (3)

Control

NO INTERVENTION

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

Physician Intervention

EXPERIMENTAL

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

Behavioral: Physician Intervention

Physician and Patient Intervention

EXPERIMENTAL

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

Behavioral: Physician and Patient Intervention

Interventions

Physician InterventionBEHAVIORAL

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 Intervention
Physician and Patient InterventionBEHAVIORAL

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

Physician and Patient Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Access Community Health Network

Chicago, Illinois, 60606, United States

Location

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • 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.

    PMID: 33416742DERIVED

  • 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.

    PMID: 26147770DERIVED

  • 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.

    PMID: 25986137DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Physicians

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Kenzie A. Cameron
Organization
Northwestern University
k-cameron@northwestern.edu
312-503-3910

Study Officials

  • Kenzie A Cameron, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 14, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

May 6, 2015

Results First Posted

September 9, 2014

Record last verified: 2015-04

Locations

US(2)