Comparing Interventions to Increase Colorectal Cancer Screening

Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03200366

Enrollment

371

Registered

2017-06-27

Start date

2017-07-26

Completion date

2020-10-21

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Cancer Screening Tests, Colonoscopy

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALTailored 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.

BEHAVIORALPatient 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Referred for a screening colonoscopy that was not done (i.e, canceled or no show)

Exclusion criteria

* Unable to speak, read, and write English * Personal history of CRC or polyps * Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer * Family history of CRC which increases the participant's risk for CRC * Advised by a health care provider to not have a colonoscopy due to the participant's health * Speech impairment * Hearing impairment * Cognitive impairment * Vision impairment

Design outcomes

Primary

Measure	Time frame	Description
Participants Completing CRC Screening Per Electronic Medical Record Documentation	12 months post-baseline interview	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.

Secondary

Measure	Time frame	Description
Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale	12 months post-baseline interview	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.
Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale	12 months post-baseline interview	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.
Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy	12 months post-baseline interview	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.
Satisfaction With Colonoscopy Experience	12 months post-baseline interview	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 Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation	12 months post-baseline interview	Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR.
Participants Who Self-Reported Completing CRC Screening	6-9 months post-baseline interview	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.
Participants Who Self-Reported Completing a Colonoscopy	6-9 months post-baseline interview	Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview.
Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)	6-9 months post-baseline interview	Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview.
Participants Completing Colonoscopy Per Electronic Medical Record Documentation	12 months post-baseline interview	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.
Change in Perceived Risk for CRC	6 months post-baseline interview	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.
Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy	6 months post-baseline interview	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.
Change in Perceived Benefits of CRC Screening by Colonoscopy	6 months post-baseline interview	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.
Change in Perceived Barriers to CRC Screening by Colonoscopy	6 months post-baseline interview	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.
Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy	6 months post-baseline interview	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.
Change in Perceived Benefits of CRC Screening by FIT	6 months post-baseline interview	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.
Change in Perceived Barriers to CRC Screening by FIT	6 months post-baseline interview	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.
Change in Perceived Self-Efficacy for CRC Screening by FIT	6 months post-baseline interview	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.
Change in Knowledge of CRC and Screening	6 months post-baseline interview	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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	123
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.	120
Usual Care Care normally provided by a nurse in the endoscopy department of the healthcare system	128
Total	371

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
6 Month Post-Baseline Interview	Death	1	1	1
6 Month Post-Baseline Interview	Lost to Follow-up	27	21	17
6 Month Post-Baseline Interview	Not attempted/missed by data collectors	0	0	1
6 Month Post-Baseline Interview	Refused 6 month interview but continued in study	1	0	0
6 Month Post-Baseline Interview	Withdrawal by Subject	1	1	0
9 Month Post-Baseline Interview	Death	1	1	1
9 Month Post-Baseline Interview	Lost to Follow-up	23	18	9
9 Month Post-Baseline Interview	Refused interview	0	2	0
9 Month Post-Baseline Interview	Withdrawal by PI	0	0	1
Patient Navigation Intervention Given	Colonoscopy already re-scheduled and completed	0	2	0
Patient Navigation Intervention Given	Death	0	2	0
Patient Navigation Intervention Given	Declined navigation intervention	0	1	0
Patient Navigation Intervention Given	Lost to Follow-up	0	25	0
Patient Navigation Intervention Given	Not attempted/missed by nurse	0	1	0

Baseline characteristics

Characteristic	Tailored DVD + Patient Navigation	Tailored DVD	Total	Usual Care
Adequacy of Income After paying the bills, there is enough money for special things that the participant wants.	16 Participants	17 Participants	53 Participants	20 Participants
Adequacy of Income The participant has difficulty paying the bills, no matter what is done.	34 Participants	36 Participants	107 Participants	37 Participants
Adequacy of Income There is enough money to pay the bills, but little spare money to buy extra or special things.	41 Participants	44 Participants	129 Participants	44 Participants
Adequacy of Income There is enough money to pay the bills, but only because the participant cuts back on things.	22 Participants	22 Participants	65 Participants	21 Participants
Age, Continuous	57.29 years STANDARD_DEVIATION 5.63	58.20 years STANDARD_DEVIATION 6.07	57.78 years STANDARD_DEVIATION 5.96	57.83 years STANDARD_DEVIATION 6.17
Body Mass Index (BMI)	30.18 kg/m^2 STANDARD_DEVIATION 7.86	31.57 kg/m^2 STANDARD_DEVIATION 8.89	31.10 kg/m^2 STANDARD_DEVIATION 8.59	31.50 kg/m^2 STANDARD_DEVIATION 8.93
Children Under Age 18 in Household	25 Participants	20 Participants	78 Participants	33 Participants
Colonoscopy-Related Procedural Anxiety	2.60 units on a scale STANDARD_DEVIATION 0.69	2.59 units on a scale STANDARD_DEVIATION 0.68	2.57 units on a scale STANDARD_DEVIATION 0.65	2.52 units on a scale STANDARD_DEVIATION 0.59
Colonoscopy Stage of Adoption Contemplation	67 Participants	70 Participants	198 Participants	61 Participants
Colonoscopy Stage of Adoption Precontemplation	25 Participants	27 Participants	81 Participants	29 Participants
Colonoscopy Stage of Adoption Preparation	28 Participants	26 Participants	92 Participants	38 Participants
Comorbidity	7.73 units on a scale STANDARD_DEVIATION 4.83	8.24 units on a scale STANDARD_DEVIATION 4.86	7.84 units on a scale STANDARD_DEVIATION 4.8	7.56 units on a scale STANDARD_DEVIATION 4.72
Education 12th grade, high school, diploma, or GED	41 Participants	42 Participants	129 Participants	46 Participants
Education 4 year college graduate, some graduate work, or completed graduate degree	12 Participants	14 Participants	38 Participants	12 Participants
Education No school through 11th grade	22 Participants	28 Participants	85 Participants	35 Participants
Education Vocational school or 1-3 years college	45 Participants	39 Participants	118 Participants	34 Participants
Employment Status Full-time	35 Participants	22 Participants	81 Participants	24 Participants
Employment Status Not employed	66 Participants	83 Participants	236 Participants	87 Participants
Employment Status Part-time	19 Participants	18 Participants	53 Participants	16 Participants
Fecal Immunochemical Test Stage of Adoption Action	12 Participants	24 Participants	51 Participants	15 Participants
Fecal Immunochemical Test Stage of Adoption Contemplation	20 Participants	23 Participants	63 Participants	20 Participants
Fecal Immunochemical Test Stage of Adoption Precontemplation	80 Participants	73 Participants	240 Participants	87 Participants
Fecal Immunochemical Test Stage of Adoption Preparation	8 Participants	3 Participants	17 Participants	6 Participants
Global Mental Health	12.73 units on a scale STANDARD_DEVIATION 3.5	12.86 units on a scale STANDARD_DEVIATION 3.19	12.82 units on a scale STANDARD_DEVIATION 3.32	12.88 units on a scale STANDARD_DEVIATION 3.31
Global Physical Health	13.37 units on a scale STANDARD_DEVIATION 3.29	12.64 units on a scale STANDARD_DEVIATION 3.24	12.96 units on a scale STANDARD_DEVIATION 3.31	12.89 units on a scale STANDARD_DEVIATION 3.38
Health Insurance Coverage	114 Participants	114 Participants	349 Participants	121 Participants
Health Literacy	11.97 units on a scale STANDARD_DEVIATION 2.64	12.20 units on a scale STANDARD_DEVIATION 2.74	12.03 units on a scale STANDARD_DEVIATION 2.87	11.91 units on a scale STANDARD_DEVIATION 3.18
Household Income $15,001-$30,000	40 Participants	46 Participants	130 Participants	44 Participants
Household Income $30,001-$50,000	20 Participants	13 Participants	48 Participants	15 Participants
Household Income $50,001 to more than $100,000	9 Participants	5 Participants	26 Participants	12 Participants
Household Income Less than $15,000	45 Participants	57 Participants	154 Participants	52 Participants
Household Income Categorized by $15K Level $15,000 or more	69 Participants	64 Participants	204 Participants	71 Participants
Household Income Categorized by $15K Level Less than $15,000	45 Participants	57 Participants	154 Participants	52 Participants
Knowledge of CRC and Screening	3.62 units on a scale STANDARD_DEVIATION 1.77	3.54 units on a scale STANDARD_DEVIATION 1.83	3.36 units on a scale STANDARD_DEVIATION 1.8	2.93 units on a scale STANDARD_DEVIATION 1.72
Married/Partnered	36 Participants	38 Participants	114 Participants	40 Participants
Number in Household 1 person	39 Participants	47 Participants	138 Participants	52 Participants
Number in Household 2 persons	44 Participants	46 Participants	123 Participants	33 Participants
Number in Household 3 or more persons	34 Participants	28 Participants	103 Participants	41 Participants
Perceived Barriers to CRC Screening by Colonoscopy	2.33 units on a scale STANDARD_DEVIATION 0.55	2.21 units on a scale STANDARD_DEVIATION 0.56	2.28 units on a scale STANDARD_DEVIATION 0.58	2.29 units on a scale STANDARD_DEVIATION 0.62
Perceived Barriers to CRC Screening by FIT	2.20 units on a scale STANDARD_DEVIATION 0.57	1.97 units on a scale STANDARD_DEVIATION 0.55	2.10 units on a scale STANDARD_DEVIATION 0.59	2.11 units on a scale STANDARD_DEVIATION 0.62
Perceived Benefits of CRC Screening by Colonoscopy	3.31 units on a scale STANDARD_DEVIATION 0.57	3.22 units on a scale STANDARD_DEVIATION 0.61	3.27 units on a scale STANDARD_DEVIATION 0.58	3.27 units on a scale STANDARD_DEVIATION 0.56
Perceived Benefits of CRC Screening by FIT	3.15 units on a scale STANDARD_DEVIATION 0.64	3.06 units on a scale STANDARD_DEVIATION 0.73	3.13 units on a scale STANDARD_DEVIATION 0.69	3.16 units on a scale STANDARD_DEVIATION 0.7
Perceived Risk for CRC	1.94 units on a scale STANDARD_DEVIATION 0.8	1.97 units on a scale STANDARD_DEVIATION 0.73	1.98 units on a scale STANDARD_DEVIATION 0.78	2.03 units on a scale STANDARD_DEVIATION 0.81
Perceived Self-Efficacy for CRC Screening by Colonoscopy	3.33 units on a scale STANDARD_DEVIATION 0.49	3.33 units on a scale STANDARD_DEVIATION 0.56	3.34 units on a scale STANDARD_DEVIATION 0.53	3.36 units on a scale STANDARD_DEVIATION 0.55
Perceived Self-Efficacy for CRC Screening by FIT	3.59 units on a scale STANDARD_DEVIATION 0.48	3.63 units on a scale STANDARD_DEVIATION 0.49	3.61 units on a scale STANDARD_DEVIATION 0.48	3.63 units on a scale STANDARD_DEVIATION 0.47
Race/Ethnicity, Customized Non-Hispanic Non-White	82 Participants	83 Participants	252 Participants	87 Participants
Race/Ethnicity, Customized Non-Hispanic Whte	33 Participants	35 Participants	104 Participants	36 Participants
Race/Ethnicity, Customized Other	5 Participants	5 Participants	15 Participants	5 Participants
Region of Enrollment United States	120 participants	123 participants	371 participants	128 participants
Sex: Female, Male Female	73 Participants	75 Participants	225 Participants	77 Participants
Sex: Female, Male Male	47 Participants	48 Participants	146 Participants	51 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	2 / 123	4 / 120	2 / 128
other Total, other adverse events	0 / 123	0 / 120	0 / 128
serious Total, serious adverse events	0 / 123	0 / 120	0 / 128

Outcome results

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.

Time frame: 12 months post-baseline interview

Population: All enrolled participants who completed the baseline interview and were randomized.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tailored DVD	Participants Completing CRC Screening Per Electronic Medical Record Documentation	37 Participants
Tailored DVD + Patient Navigation	Participants Completing CRC Screening Per Electronic Medical Record Documentation	59 Participants
Usual Care	Participants Completing CRC Screening Per Electronic Medical Record Documentation	27 Participants

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.

Time frame: 12 months post-baseline interview

Population: All participants who completed a colonoscopy per EMR documentation. Analysis excludes 1 participant in Usual Care group whose BBPS score was missing.

Arm	Measure	Value (MEAN)	Dispersion
Tailored DVD	Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale	7.13 score on a scale	Standard Deviation 1.9
Tailored DVD + Patient Navigation	Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale	6.59 score on a scale	Standard Deviation 2.4
Usual Care	Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale	7.05 score on a scale	Standard Deviation 2.44

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.