Comparing Interventions to Increase Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200366
• Other study ID #: 1605880142
• Secondary ID: IHS-1507-31333
• Status: Completed
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: October 21, 2020

Study information

• Verified date: August 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana
United States	Indiana University School of Nursing	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Ohio State University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	12 months post-baseline interview
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.	6-9 months post-baseline interview
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.	6-9 months post-baseline interview
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.	6-9 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview
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.	6 months post-baseline interview