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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

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ClinicalTrials.gov Identifier: NCT01103479
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : September 9, 2014
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition Colorectal Cancer
Interventions Behavioral: Physician Intervention
Behavioral: Physician and Patient Intervention
Enrollment 569
Recruitment Details Recruitment for this study took place between September 15, 2010 and January 30, 2013 across seven federally qualified health centers as well as one large academic health center.
Pre-assignment Details Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach the point in the pre-test survey where randomization took place. Therefore they were not assigned to groups. In this study, 3 of the 569 enrolled participants did not reach randomization.
Arm/Group Title Control Physician Intervention Physician and Patient Intervention
Hide Arm/Group 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

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

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

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

Period Title: Overall Study
Started 168 210 188
Completed 163 201 174
Not Completed 5 9 14
Reason Not Completed
Up to date with CRC screening             1             9             12
Family history of CRC             1             0             2
Active cancer             1             0             0
Saw non-study physician             2             0             0
Arm/Group Title Control Physician Intervention Physician and Patient Intervention Total
Hide Arm/Group 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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 163 201 174 538
Hide Baseline Analysis Population Description
Participants had to reach randomization, complete both pre and post-tests, and be eligible for colorectal cancer screening (verified by chart review).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 201 participants 174 participants 538 participants
57.46  (6.07) 58.71  (6.24) 57.03  (6.09) 57.79  (6.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Female
124
  76.1%
144
  71.6%
129
  74.1%
397
  73.8%
Male
39
  23.9%
57
  28.4%
45
  25.9%
141
  26.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Non-Hispanic Black 82 111 93 286
Hispanic 68 88 75 231
Other/Missing 13 2 6 21
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 163 participants 201 participants 174 participants 538 participants
163 201 174 538
Survey Language  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
English 100 118 106 324
Spanish 63 83 68 214
Insurance Status (more than one may apply)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Private 21 30 27 78
Medicare 47 68 52 167
Medicaid 51 71 67 189
Uninsured 66 52 42 160
Health Care System  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Community FQHC 99 174 154 427
Academic Health Center 64 27 20 111
Years of Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
0 - 6 years 44 38 35 117
7 - 12 years 41 64 52 157
13 or more years 76 98 86 260
Missing data 2 1 1 4
Household Income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
<$20,000/year 101 137 111 349
$20,000 - $40,000/year 22 28 23 73
$40,001 - $100,000/year 13 6 8 27
Not sure/Don't know 23 26 27 76
Refused/Missing 4 4 5 13
Health status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Poor 28 28 25 81
Fair 75 107 88 270
Good 39 46 44 129
Very Good 18 10 12 40
Excellent 2 10 4 16
Missing 1 0 1 2
Health Literacy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 201 participants 174 participants 538 participants
Inadequate 51 86 67 204
Marginal/Adequate 96 97 88 281
Missing 16 18 19 53
1.Primary Outcome
Title Colorectal Cancer (CRC) Screening Completion
Hide Description CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Time Frame within 6 months of provider recommendation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
Participants will complete interviewer-administered pre- and post-test

Participants in either the Physician Intervention or Physician and Patient Intervention Arms.

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

Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

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 co

Overall Number of Participants Analyzed 163 375
Measure Type: Number
Unit of Measure: participants
17 69
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments Random effects model adjusting for clustering by clinic
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
0.62 to 4.38
Estimation Comments [Not Specified]
2.Primary Outcome
Title Colorectal Cancer (CRC) Screening Completion
Hide Description CRC screening completion via FOBT, FIT or Colonoscopy
Time Frame within 6 months of provider recommendation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physician Intervention Physician and Patient Intervention
Hide Arm/Group 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

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

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

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

Overall Number of Participants Analyzed 201 174
Measure Type: Number
Unit of Measure: participants
41 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Intervention, Physician and Patient Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments Linear model adjusting for stratification by clinic and participant age
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.53 to 1.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Provider Recommendation of CRC Screening
Hide Description Provider recommendation of CRC Screening based on chart review
Time Frame 6 months following patient enrollment into study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
Participants will complete interviewer-administered pre- and post-test

Participants in either the Physician Intervention or Physician and Patient Intervention Arms.

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

Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

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 co

Overall Number of Participants Analyzed 163 375
Measure Type: Number
Unit of Measure: participants
70 216
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments Random effects model adjusted for clustering by clinic
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
0.60 to 3.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Provider Recommendation of CRC Screening
Hide Description Provider recommendation of CRC Screening based on chart review
Time Frame 6 months following patient enrollment into study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physician Intervention Physician and Patient Intervention
Hide Arm/Group 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

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

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

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

Overall Number of Participants Analyzed 201 174
Measure Type: Number
Unit of Measure: participants
113 103
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physician Intervention, Physician and Patient Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments Linear model adjusting for stratification by clinic and participant age
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.94 to 1.18
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Physician Training Physician and Patient Intervention
Hide Arm/Group 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

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

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

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

All-Cause Mortality
Control Physician Training Physician and Patient Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Physician Training Physician and Patient Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/201 (0.00%)   0/174 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Physician Training Physician and Patient Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/201 (0.00%)   0/174 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kenzie A. Cameron
Organization: Northwestern University
Phone: 312-503-3910
Responsible Party: Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier: NCT01103479     History of Changes
Other Study ID Numbers: R01CA140177-01 ( U.S. NIH Grant/Contract )
R01CA140177 ( U.S. NIH Grant/Contract )
First Submitted: April 12, 2010
First Posted: April 14, 2010
Results First Submitted: August 28, 2014
Results First Posted: September 9, 2014
Last Update Posted: May 6, 2015