Comparing Interventions to Increase Colorectal Cancer Screening
2 other identifiers
interventional
371
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Jul 2017
Typical duration for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2020
CompletedResults Posted
Study results publicly available
September 13, 2021
CompletedSeptember 13, 2021
August 1, 2021
3.2 years
June 22, 2017
June 8, 2021
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Participants Completing Colonoscopy Per Electronic Medical Record Documentation
12 months post-baseline interview
Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale
12 months post-baseline interview
Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale
12 months post-baseline interview
Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy
12 months post-baseline interview
Satisfaction With Colonoscopy Experience
12 months post-baseline interview
- +13 more secondary outcomes
Study Arms (3)
Tailored DVD
ACTIVE COMPARATORTailored digital video disc (DVD)
Tailored DVD + Patient Navigation
ACTIVE COMPARATORTailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system
Usual Care
NO INTERVENTIONCare normally provided by a nurse in the endoscopy department of the healthcare system
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Patient-Centered Outcomes Research Institutecollaborator
- Ohio State Universitycollaborator
Study Sites (2)
Eskenazi Health
Indianapolis, Indiana, 46202, United States
Indiana University School of Nursing
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan M. Rawl, PhD, RN, FAAHB, FAAN
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Rawl, PhD,RN
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2017
First Posted
June 27, 2017
Study Start
July 26, 2017
Primary Completion
October 21, 2020
Study Completion
October 21, 2020
Last Updated
September 13, 2021
Results First Posted
September 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Available by September 30, 2021
- Access Criteria
- Request in writing to the the study's Principal Investigator, Dr. Susan Rawl
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.