Colorectal Cancer
Conditions
Keywords
Early Detection of Cancer, Colorectal Cancer Screening
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.
Interventions
BEHAVIORALPhysician 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
BEHAVIORALPhysician 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
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer (CRC) Screening Completion | within 6 months of provider recommendation | CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Recommendation of CRC Screening | 6 months following patient enrollment into study | Provider recommendation of CRC Screening based on chart review |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants will complete interviewer-administered pre- and post-test | 163 |
| 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
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 | 201 |
| 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
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 | 174 |
| Total | 538 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Active cancer | 1 | 0 | 0 |
| Overall Study | Family history of CRC | 1 | 0 | 2 |
| Overall Study | Saw non-study physician | 2 | 0 | 0 |
| Overall Study | Up to date with CRC screening | 1 | 9 | 12 |
Baseline characteristics
| Characteristic | Total | Physician Intervention | Physician and Patient Intervention | Control |
|---|---|---|---|---|
| Age, Continuous | 57.79 years STANDARD_DEVIATION 6.17 | 58.71 years STANDARD_DEVIATION 6.24 | 57.03 years STANDARD_DEVIATION 6.09 | 57.46 years STANDARD_DEVIATION 6.07 |
| Health Care System Academic Health Center | 111 participants | 27 participants | 20 participants | 64 participants |
| Health Care System Community FQHC | 427 participants | 174 participants | 154 participants | 99 participants |
| Health Literacy Inadequate | 204 participants | 86 participants | 67 participants | 51 participants |
| Health Literacy Marginal/Adequate | 281 participants | 97 participants | 88 participants | 96 participants |
| Health Literacy Missing | 53 participants | 18 participants | 19 participants | 16 participants |
| Health status Excellent | 16 participants | 10 participants | 4 participants | 2 participants |
| Health status Fair | 270 participants | 107 participants | 88 participants | 75 participants |
| Health status Good | 129 participants | 46 participants | 44 participants | 39 participants |
| Health status Missing | 2 participants | 0 participants | 1 participants | 1 participants |
| Health status Poor | 81 participants | 28 participants | 25 participants | 28 participants |
| Health status Very Good | 40 participants | 10 participants | 12 participants | 18 participants |
| Household Income $20,000 - $40,000/year | 73 participants | 28 participants | 23 participants | 22 participants |
| Household Income <$20,000/year | 349 participants | 137 participants | 111 participants | 101 participants |
| Household Income $40,001 - $100,000/year | 27 participants | 6 participants | 8 participants | 13 participants |
| Household Income Not sure/Don't know | 76 participants | 26 participants | 27 participants | 23 participants |
| Household Income Refused/Missing | 13 participants | 4 participants | 5 participants | 4 participants |
| Insurance Status (more than one may apply) Medicaid | 189 participants | 71 participants | 67 participants | 51 participants |
| Insurance Status (more than one may apply) Medicare | 167 participants | 68 participants | 52 participants | 47 participants |
| Insurance Status (more than one may apply) Private | 78 participants | 30 participants | 27 participants | 21 participants |
| Insurance Status (more than one may apply) Uninsured | 160 participants | 52 participants | 42 participants | 66 participants |
| Race/Ethnicity, Customized Hispanic | 231 participants | 88 participants | 75 participants | 68 participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 286 participants | 111 participants | 93 participants | 82 participants |
| Race/Ethnicity, Customized Other/Missing | 21 participants | 2 participants | 6 participants | 13 participants |
| Region of Enrollment United States | 538 participants | 201 participants | 174 participants | 163 participants |
| Sex: Female, Male Female | 397 Participants | 144 Participants | 129 Participants | 124 Participants |
| Sex: Female, Male Male | 141 Participants | 57 Participants | 45 Participants | 39 Participants |
| Survey Language English | 324 participants | 118 participants | 106 participants | 100 participants |
| Survey Language Spanish | 214 participants | 83 participants | 68 participants | 63 participants |
| Years of Education 0 - 6 years | 117 participants | 38 participants | 35 participants | 44 participants |
| Years of Education 13 or more years | 260 participants | 98 participants | 86 participants | 76 participants |
| Years of Education 7 - 12 years | 157 participants | 64 participants | 52 participants | 41 participants |
| Years of Education Missing data | 4 participants | 1 participants | 1 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 163 | 0 / 201 | 0 / 174 |
| serious Total, serious adverse events | 0 / 163 | 0 / 201 | 0 / 174 |
Outcome results
Primary
Colorectal Cancer (CRC) Screening Completion
CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Time frame: within 6 months of provider recommendation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Colorectal Cancer (CRC) Screening Completion | 17 participants |
| Intervention | Colorectal Cancer (CRC) Screening Completion | 69 participants |
p-value: 0.3295% CI: [0.62, 4.38]Mixed Models Analysis
Primary
Colorectal Cancer (CRC) Screening Completion
CRC screening completion via FOBT, FIT or Colonoscopy
Time frame: within 6 months of provider recommendation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Colorectal Cancer (CRC) Screening Completion | 41 participants |
| Intervention | Colorectal Cancer (CRC) Screening Completion | 28 participants |
p-value: 0.2895% CI: [0.53, 1.2]Mixed Models Analysis
Secondary
Provider Recommendation of CRC Screening
Provider recommendation of CRC Screening based on chart review
Time frame: 6 months following patient enrollment into study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Provider Recommendation of CRC Screening | 70 participants |
| Intervention | Provider Recommendation of CRC Screening | 216 participants |
p-value: 0.4295% CI: [0.6, 3.43]Mixed Models Analysis
Secondary
Provider Recommendation of CRC Screening
Provider recommendation of CRC Screening based on chart review
Time frame: 6 months following patient enrollment into study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Provider Recommendation of CRC Screening | 113 participants |
| Intervention | Provider Recommendation of CRC Screening | 103 participants |
p-value: 0.3895% CI: [0.94, 1.18]Mixed Models Analysis