N/A N=371 Randomized Screening

Comparing Interventions to Increase Colorectal Cancer Screening

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03200366 ↗

Enrolled (actual)

371

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Participants Completing CRC Screening Per Electronic Medical Record Documentation — 37; 59; 27 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tailored DVD (Behavioral); Patient Navigation (Behavioral)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Completing CRC Screening Per Electronic Medical Record Documentation	37; 59; 27	—
SECONDARY Participants Completing Colonoscopy Per Electronic Medical Record Documentation	24; 46; 20	—
SECONDARY Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale	7.13; 6.59; 7.05	—
SECONDARY Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale	22; 39; 18	—
SECONDARY Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy	2.46; 2.23; 2.28	—
SECONDARY Satisfaction With Colonoscopy Experience	3.38; 3.60; 3.13	—
SECONDARY Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation	15; 13; 8	—
SECONDARY Participants Who Self-Reported Completing CRC Screening	48; 59; 43	—
SECONDARY Participants Who Self-Reported Completing a Colonoscopy	26; 46; 27	—
SECONDARY Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)	34; 28; 20	—
SECONDARY Change in Knowledge of CRC and Screening	1.14; 1.32; 0.75	—
SECONDARY Change in Perceived Risk for CRC	0.23; 0.03; 0.18	—
SECONDARY Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy	-0.13; -0.23; -0.05	—
SECONDARY Change in Perceived Benefits of CRC Screening by Colonoscopy	0.18; 0.16; 0.04	—
SECONDARY Change in Perceived Barriers to CRC Screening by Colonoscopy	-0.21; 0.01; -0.15	—
SECONDARY Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy	0.15; 0.20; 0.06	—
SECONDARY Change in Perceived Benefits of CRC Screening by FIT	0.08; 0.07; -0.02	—
SECONDARY Change in Perceived Barriers to CRC Screening by FIT	-0.18; -0.11; -0.16	—
SECONDARY Change in Perceived Self-Efficacy for CRC Screening by FIT	0.07; 0.18; 0.10	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03200366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.