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| ID | Type | Description | Link |
|---|---|---|---|
| IHS-1507-31333 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Ohio State University | OTHER |
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The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.
Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored DVD | Active Comparator | Tailored digital video disc (DVD) |
|
| Tailored DVD + Patient Navigation | Active Comparator | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system |
|
| Usual Care | No Intervention | Care normally provided by a nurse in the endoscopy department of the healthcare system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored DVD | Behavioral | A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Completing CRC Screening Per Electronic Medical Record Documentation | Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record. | 12 months post-baseline interview |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Completing Colonoscopy Per Electronic Medical Record Documentation | Number of participants completing a colonoscopy is measured by electronic medical record review (EMR). Dates that participants completed a colonoscopy are extracted from the EMR. | 12 months post-baseline interview |
| Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Rawl, PhD,RN | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University School of Nursing |
A copy of the complete, cleaned, de-identified data set used to conduct the final analyses will be made available in SAS and SPSS formats.
Available by September 30, 2021
Request in writing to the the study's Principal Investigator, Dr. Susan Rawl
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Participants were 371 primary care patients from Eskenazi Health clinics located ln Indianapolis, Indiana. Participants were recruited between July 2017 to November 2019. Participants were enrolled after providing informed consent and HIPAA authorization to obtain CRC screening information from their electronic medical record (EMR). EMR was reviewed for completion of CRC screening by colonoscopy and FIT for ALL participants, regardless of whether or not post-baseline interviews were completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored DVD | Tailored digital video disc (DVD) DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. |
| FG001 | Tailored DVD + Patient Navigation | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. |
| FG002 | Usual Care | Care normally provided by a nurse in the endoscopy department of the healthcare system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Interview With Randomization |
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| Tailored DVD Intervention Given |
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| Patient Navigation Intervention Given |
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| 6 Month Post-Baseline Interview |
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| 9 Month Post-Baseline Interview |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored DVD | Tailored digital video disc (DVD) DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Completing CRC Screening Per Electronic Medical Record Documentation | Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record. | All enrolled participants who completed the baseline interview and were randomized. | Posted | Count of Participants | Participants | 12 months post-baseline interview |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored DVD | Tailored digital video disc (DVD) Tailored DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan M. Rawl, PhD, RN, FAAHB, FAAN | Indiana University | 317-278-2217 | srawl@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2019 | May 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Patient Navigation | Behavioral | Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. |
|
Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS). BBPS scores the total quality on a 10 point scale from 0-9. Higher scores indicate better quality of bowel preparation. |
| 12 months post-baseline interview |
| Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale | Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale. The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor. Some endoscopists choose to grade quality more generally as adequate vs. inadequate. To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings). Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is scored as 0. | 12 months post-baseline interview |
| Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy | Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. | 12 months post-baseline interview |
| Satisfaction With Colonoscopy Experience | Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team. Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied. Scores range from 1 to 4 with higher scores indicating greater satisfaction. | 12 months post-baseline interview |
| Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation | Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR. | 12 months post-baseline interview |
| Participants Who Self-Reported Completing CRC Screening | Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview. | 6-9 months post-baseline interview |
| Participants Who Self-Reported Completing a Colonoscopy | Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview. | 6-9 months post-baseline interview |
| Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT) | Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview. | 6-9 months post-baseline interview |
| Change in Knowledge of CRC and Screening | Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests. The mean of the 9 items is calculated at baseline and 6 months post-baseline. Change from baseline equals the mean at 6 months minus the mean at baseline. Change can range from -9 to 9 with positive values indicating an increase in knowledge. | 6 months post-baseline interview |
| Change in Perceived Risk for CRC | Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely). Higher scores indicate a higher perceived risk for getting CRC. The mean of the 3 items is calculated at baseline and 6 months. Change in perceived risk equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived risk for getting CRC. | 6 months post-baseline interview |
| Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy | Change from baseline in colonoscopy-related procedural anxiety is measured at 6 months by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. The mean of the 6 items is calculated at baseline and 6 months post-baseline. Change from baseline is the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in anxiety. | 6 months post-baseline interview |
| Change in Perceived Benefits of CRC Screening by Colonoscopy | Change from baseline in perceived benefits of CRC screening by colonoscopy is measured at 6 months by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits of screening by colonoscopy. | 6 months post-baseline interview |
| Change in Perceived Barriers to CRC Screening by Colonoscopy | Change from baseline in perceived barriers to CRC screening by colonoscopy is measured at 6 months by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by colonoscopy. | 6 months post-baseline interview |
| Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy | Change from baseline in perceived self-efficacy for colonoscopy is measured at 6 months by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by colonoscopy. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by colonoscopy. | 6 months post-baseline interview |
| Change in Perceived Benefits of CRC Screening by FIT | Change from baseline in perceived benefits of CRC screening by FIT is measured at 6 months by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits for screening by FIT. | 6 months post-baseline interview |
| Change in Perceived Barriers to CRC Screening by FIT | Change from baseline in perceived barriers to CRC screening by FIT is measured at 6 months by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by FIT. | 6 months post-baseline interview |
| Change in Perceived Self-Efficacy for CRC Screening by FIT | Change from baseline in perceived self-efficacy for CRC screening by FIT is measured at 6 months by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by FIT. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by FIT. | 6 months post-baseline interview |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Tailored DVD + Patient Navigation | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. |
| BG002 | Usual Care | Care normally provided by a nurse in the endoscopy department of the healthcare system |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Married/Partnered | Participants who are either married or living with a partner. | Enrolled participants who completed the baseline interview. Excludes 1 participant from the Tailored DVD + Patient Navigation group whose data were missing. | Count of Participants | Participants |
|
| Education | Participants highest grade or year of school completed. | Enrolled participants who completed the baseline interview. Excludes 1 participant in Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Number in Household | Number of persons, including the participant, who live in their household. | Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data were missing. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Children Under Age 18 in Household | Participants with children younger than 18 living in their household. | Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Employment Status | Enrolled participants who completed the baseline interview. Excludes 1 participant in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Household Income | Total combined yearly household income before taxes. | Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 5 participants in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Household Income Categorized by $15K Level | Total combined yearly household income before taxes, categorized as below $15,000 vs. $15,000 or more. | Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 5 participants in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Adequacy of Income | Participants described the adequacy of their household income to pay for things. | Enrolled participants who completed the baseline interview. Excludes 4 participants in the Tailored DVD group whose data were missing. Excludes 7 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 6 participants in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Health Insurance Coverage | Participants covered by health insurance or some other kind of health care plan. | Enrolled participants who completed the baseline interview. Excludes 1 participant in the Usual Care group whose data were missing. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body mass index (BMI) is an estimate of body fat that is calculated using participants self report of height and weight. BMI values are correlated with weight categories. A BMI <18.5 means underweight; BMI=18.5-24.9 means normal weight; BMI=25.0-29.9 means overweight; and BMI > 30 means obese. A high BMI is associated with an increased risk for chronic diseases such as heart disease, high blood pressure, and type 2 diabetes. | Enrolled participants who completed the baseline interview. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing. | Mean | Standard Deviation | kg/m^2 |
|
| Global Physical Health | Global physical health status was measured using the subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS) validated instrument. The subscale uses 4 items and measures general physical health, physical functioning, pain, and fatigue. Response options range from 1=poor to 5=excellent. Scores range from a minimum of 4 to a maximum of 20. Higher scores indicate better physical health. | Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 3 participants in the Usual Care group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Global Mental Health | Global mental health status was measured using the subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS) validated instrument. The subscale uses 4 items and measures quality of life, general mental health, satisfaction with social activities/relationships, and emotional problems. Response options range from 1=poor to 5=excellent. Scores range from a minimum of 4 to a maximum of 20. Higher scores indicate better mental health. | Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Health Literacy | Health literacy was measured using Chew's Brief Health Literacy Screen validated instrument. This 3-item scale assesses participants' confidence in filling out medical forms independently, if they need help from others to read hospital materials, and if they have problems learning about their medical condition because of difficulty understanding written information. Recoded response options range from 1=no confidence/always need help/always difficult to 5=extremely confident/never need help/never difficult. Scores range from 3 to 15. Higher scores indicate greater health literacy. | Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Comorbidity | Comorbidity was measured by self-report using Sangha's comordibity questionnaire. Twelve common health problems (heart disease, high blood pressure, diabetes, etc.) are assessed by asking participants if they ever had the problem, if they currently receive treatment for it, and if it currently limits their activities. Each question is scored as yes=1 or no=0 resulting in a possible score of 0 to 3 per health problem. Scale scores range from 0 to 36. Higher scale scores indicate greater comorbidity. | Mean | Standard Deviation | units on a scale |
|
| Knowledge of CRC and Screening | Knowledge of CRC and screening is measured by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect, summed to yield a scale score, and the mean calculated. Scores range from 0 to 9. Higher scale scores and means indicate greater knowledge of CRC and screening tests. | Mean | Standard Deviation | units on a scale |
|
| Perceived Risk for CRC | Perceived risk for CRC is measured by self-report using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely) and the mean of the 3 items calculated. Higher mean scores indicate a greater perceived risk for getting CRC. | Enrolled participants who completed the baseline interview. Excludes 9 participants in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 4 participants in the Usual Care group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Colonoscopy Stage of Adoption | Participants staged in terms of their readiness screen for CRC by having a colonoscopy. If not planning to have a colonoscopy in the next 6 months, staging was precontemplation. If planning to have a colonoscopy in the next 6 months, but no appointment scheduled, staging was contemplation. If an appointment was scheduled to have a colonoscopy within the next 6 months, staging was preparation. | Count of Participants | Participants |
|
| Colonoscopy-Related Procedural Anxiety | Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) and the mean of the 4 items calculated. Higher mean scores indicate greater anxiety. | Excludes 1 participant in the Tailored DVD group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Perceived Benefits of CRC Screening by Colonoscopy | Perceived benefits of CRC screening by colonoscopy is measured by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy. | Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data was missing. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data was missing. | Mean | Standard Deviation | units on a scale |
|
| Perceived Barriers to CRC Screening by Colonoscopy | Perceived barriers to colonoscopy is measured by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy. | Mean | Standard Deviation | units on a scale |
|
| Perceived Self-Efficacy for CRC Screening by Colonoscopy | Perceived self-efficacy for colonoscopy is measured by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for CRC screening by colonoscopy. | Mean | Standard Deviation | units on a scale |
|
| Fecal Immunochemical Test Stage of Adoption | Participants staged in terms of their readiness to adopt an at-home fecal immunochemical test (FIT) to screen for CRC. If not planning to do a FIT in the next 6 months, staging was precontemplation. If planning to do a FIT in the next 6 months, but did not have a FIT kit at home, staging was contemplation. If planning to do a FIT within the next 6 months and had a FIT kit at home, staging was preparation. If a FIT was already done within the last 12 months, staging was action. | Count of Participants | Participants |
|
| Perceived Benefits of CRC Screening by FIT | Perceived benefits of CRC screening by FIT is measured by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT. | Enrolled participants who completed the baseline interview. Excludes 6 participants in the Tailored DVD group whose data were missing. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing. | Mean | Standard Deviation | units on a scale |
|
| Perceived Barriers to CRC Screening by FIT | Perceived barriers to FIT is measured by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT. | Mean | Standard Deviation | units on a scale |
|
| Perceived Self-Efficacy for CRC Screening by FIT | Perceived self-efficacy for FIT is measured by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for CRC screening by FIT. | Mean | Standard Deviation | units on a scale |
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| OG001 | Tailored DVD + Patient Navigation | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. |
| OG002 | Usual Care | Care normally provided by a nurse in the endoscopy department of the healthcare system |
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| Secondary | Participants Completing Colonoscopy Per Electronic Medical Record Documentation | Number of participants completing a colonoscopy is measured by electronic medical record review (EMR). Dates that participants completed a colonoscopy are extracted from the EMR. | All enrolled participants who completed the baseline interview and were randomized. | Posted | Count of Participants | Participants | 12 months post-baseline interview |
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| Secondary | Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale | Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS). BBPS scores the total quality on a 10 point scale from 0-9. Higher scores indicate better quality of bowel preparation. | All participants who completed a colonoscopy per EMR documentation. Analysis excludes 1 participant in Usual Care group whose BBPS score was missing. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-baseline interview |
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| Secondary | Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale | Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale. The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor. Some endoscopists choose to grade quality more generally as adequate vs. inadequate. To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings). Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is scored as 0. | All participants who completed a colonoscopy per EMR documentation. | Posted | Count of Participants | Participants | 12 months post-baseline interview |
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| Secondary | Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy | Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. | Participants who completed a colonoscopy within 12 months of the baseline interview per EMR documentation and self-reported on colonoscopy-related anxiety during the 6 or 9 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose anxiety data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose anxiety data were missing. Excludes 4 participants in the Usual Care group whose anxiety data were missing. | Posted | Mean | Standard Deviation | units on a scale | 12 months post-baseline interview |
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| Secondary | Satisfaction With Colonoscopy Experience | Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team. Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied. Scores range from 1 to 4 with higher scores indicating greater satisfaction. | Participants who completed a colonoscopy within 12 months of the baseline interview per EMR documentation and self-reported their satisfaction with the experience during the 6 or 9 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose satisfaction data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose satisfaction data were missing. Excludes 4 participants in the Usual Care group whose satisfaction data were missing. | Posted | Mean | Standard Deviation | units on a scale | 12 months post-baseline interview |
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| Secondary | Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation | Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR. | All enrolled participants who completed the baseline interview and were randomized. | Posted | Count of Participants | Participants | 12 months post-baseline interview |
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| Secondary | Participants Who Self-Reported Completing CRC Screening | Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview. | CRC screening self-reported during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Count of Participants | Participants | 6-9 months post-baseline interview |
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| Secondary | Participants Who Self-Reported Completing a Colonoscopy | Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview. | Colonoscopy completed per self-report during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Count of Participants | Participants | 6-9 months post-baseline interview |
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| Secondary | Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT) | Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview. | FIT completed per self-report during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Count of Participants | Participants | 6-9 months post-baseline interview |
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| Secondary | Change in Knowledge of CRC and Screening | Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests. The mean of the 9 items is calculated at baseline and 6 months post-baseline. Change from baseline equals the mean at 6 months minus the mean at baseline. Change can range from -9 to 9 with positive values indicating an increase in knowledge. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in the Usual Care group due to the data being contradictory/invalid. | Posted | Mean | Standard Error | score on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Risk for CRC | Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely). Higher scores indicate a higher perceived risk for getting CRC. The mean of the 3 items is calculated at baseline and 6 months. Change in perceived risk equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived risk for getting CRC. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 7 participants in the Tailored DVD group whose data were missing. Excludes 5 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 8 participants in the Usual Care group whose data were missing and 1 participant in the Usual Care group due to the data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy | Change from baseline in colonoscopy-related procedural anxiety is measured at 6 months by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. The mean of the 6 items is calculated at baseline and 6 months post-baseline. Change from baseline is the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in anxiety. | Participants who self-reported their colonoscopy-related anxiety during the 6 month post-baseline interview, regardless of their colonoscopy completion status. Excludes 1 participant in the Tailored DVD group whose data was missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group due to data being missing for 1 participant and data being contradictory/invalid for 1 participant. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Benefits of CRC Screening by Colonoscopy | Change from baseline in perceived benefits of CRC screening by colonoscopy is measured at 6 months by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits of screening by colonoscopy. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 3 participants in the Tailored DVD group whose data was missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data was missing. Excludes 2 participants in the Usual Care group due to data being missing for 1 participant and data being contradictory/invalid for 1 participant. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Barriers to CRC Screening by Colonoscopy | Change from baseline in perceived barriers to CRC screening by colonoscopy is measured at 6 months by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by colonoscopy. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy | Change from baseline in perceived self-efficacy for colonoscopy is measured at 6 months by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by colonoscopy. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by colonoscopy. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Benefits of CRC Screening by FIT | Change from baseline in perceived benefits of CRC screening by FIT is measured at 6 months by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits for screening by FIT. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose data were missing. Excludes 5 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing and 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Barriers to CRC Screening by FIT | Change from baseline in perceived barriers to CRC screening by FIT is measured at 6 months by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by FIT. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| Secondary | Change in Perceived Self-Efficacy for CRC Screening by FIT | Change from baseline in perceived self-efficacy for CRC screening by FIT is measured at 6 months by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by FIT. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by FIT. | Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in Usual Care group due to data being contradictory/invalid. | Posted | Mean | Standard Deviation | units on a scale | 6 months post-baseline interview |
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| 2 |
| 123 |
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | Tailored DVD + Patient Navigation | Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system Tailored DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed. Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support. | 4 | 120 | 0 | 120 | 0 | 120 |
| EG002 | Usual Care | Care normally provided by a nurse in the endoscopy department of the healthcare system | 2 | 128 | 0 | 128 | 0 | 128 |
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006298 | Health Services Administration |
| Male |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| 12th grade, high school, diploma, or GED |
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| Vocational school or 1-3 years college |
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| 4 year college graduate, some graduate work, or completed graduate degree |
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| 2 persons |
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| 3 or more persons |
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| Part-time |
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| Full-time |
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| $15,001-$30,000 |
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| $30,001-$50,000 |
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| $50,001 to more than $100,000 |
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| $15,000 or more |
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| There is enough money to pay the bills, but little spare money to buy extra or special things. |
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| There is enough money to pay the bills, but only because the participant cuts back on things. |
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| The participant has difficulty paying the bills, no matter what is done. |
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| Contemplation |
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| Preparation |
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| Contemplation |
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| Preparation |
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| Action |
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