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Comparing Interventions to Increase Colorectal Cancer Screening

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ClinicalTrials.gov Identifier: NCT03200366
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2017
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Ohio State University
Information provided by (Responsible Party):
Susan Rawl, Indiana University

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: DVD Behavioral: Patient Navigation Not Applicable

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 750 men and women aged 50-75 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DVD
Tailored digital video disc (DVD)
Behavioral: 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.

Active Comparator: DVD + Patient Navigation
Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system
Behavioral: 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.

Behavioral: Patient Navigation
Participants talk by telephone with a Patient Navigator who is a population health nurse in the healthcare system. 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.

No Intervention: Usual Care
Care normally provided by a nurse in the endoscopy department of the healthcare system



Primary Outcome Measures :
  1. Number of Participants Completing CRC Screening [ Time Frame: 9 months post-baseline interview ]
    Number of participants completing CRC screening by any test (colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates that participants returned FIT kits are extracted from the electronic medical record.


Secondary Outcome Measures :
  1. 1-Item Bowel Preparation Quality Rating [ Time Frame: 9 months post-baseline interview ]
    For participants who complete a colonoscopy, quality of bowel preparation is measured by endoscopists using a single item. Quality is rated on a scale from 1 to 4 where 1=excellent, 2=good, 3=fair, and 4=poor. Scores range from 1 to 4 with lower scores indicating better quality of the bowel preparation.

  2. Colonoscopy-Related Procedural Anxiety [ Time Frame: 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) yielding a total score between 6 to 24. Lower summated scores indicate less anxiety.

  3. Change from Baseline in Colonoscopy-Related Procedural Anxiety at 6 Months [ Time Frame: 6 months post-baseline interview ]
    For participants who complete a colonoscopy within 6 months of the baseline interview, the change from baseline in 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) yielding a total score between 6 to 24. Lower summated scores indicate less anxiety.

  4. Change from Baseline in Colonoscopy-Related Procedural Anxiety Between 6 and 9 Months [ Time Frame: 9 months post-baseline interview ]
    For participants who complete a colonoscopy in the three month interim between the 6 and 9 month interviews, the change from baseline in 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) yielding a total score between 6 to 24. Lower summated scores indicate less anxiety.

  5. 1-Item Colonoscopy Satisfaction Measure at 6 Months [ Time Frame: 6 months post-baseline interview ]
    For participants who complete a colonoscopy within 6 months of the baseline interview, satisfaction with the colonoscopy experience is measured by self-report using a single item. 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.

  6. 1-Item Colonoscopy Satisfaction Measure Between 6 and 9 Months [ Time Frame: 9 months post-baseline interview ]
    For participants who complete a colonoscopy in the three month interim between the 6 and 9 month interviews, satisfaction with the colonoscopy experience is measured by self-report using a single item. 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.

  7. 9-Item Knowledge of CRC and Screening Measure [ Time Frame: Baseline interview ]
    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. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests..

  8. Change from Baseline in 9-Item Knowledge of CRC and Screening Measure at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests..

  9. Perceived Risk for CRC [ Time Frame: Baseline interview ]
    Perceived risk for CRC is assessed by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely) yielding a total score between 4 to 16. Higher summated scores indicate a higher perceived risk for getting CRC.

  10. Change from Baseline in Perceived Risk for CRC at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in perceived risk for CRC is assessed by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely) yielding a total score between 4 to 16. Higher summated scores indicate a higher perceived risk for getting CRC.

  11. 1-Item Baseline Measure of Comparative Perceived Risk for Getting CRC [ Time Frame: Baseline interview ]
    Perceived risk for getting CRC compared to others of the same gender and age is measured by self-report using a single item. Comparative risk is scored from 1 to 3 where 1=higher than other men/women of the same age, 2=about the same as other men/women of the same age, and 3=lower than other men/women of the same age. Scores range from 1 to 3 and are reverse-coded so that higher scores indicate a higher comparative perceived risk for getting CRC.

  12. Change from Baseline in 1-Item Comparative Perceived Risk for Getting CRC as Measured at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in perceived risk for getting CRC compared to others of the same gender and age is measured by self-report using a single item. Comparative risk is scored from 1 to 3 where 1=higher than other men/women of the same age, 2=about the same as other men/women of the same age, and 3=lower than other men/women of the same age. Scores range from 1 to 3 and are reverse-coded so higher scores indicate a higher comparative perceived risk for getting CRC.

  13. Perceived Benefits of CRC Screening by Colonoscopy [ Time Frame: Baseline interview ]
    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) yielding a total score between 4 to 16. Higher summated scores indicate higher perceived benefits of screening by colonoscopy..

  14. Change from Baseline in Perceived Benefits of CRC Screening by Colonoscopy at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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) yielding a total score between 4 to 16. Higher summated scores indicate higher perceived benefits of screening by colonoscopy..

  15. Perceived Benefits of CRC Screening by FIT [ Time Frame: Baseline interview ]
    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) yielding a total score between 3 to 12. Higher summated scores indicate higher perceived benefits of screening by FIT.

  16. Change from Baseline in Perceived Benefits of CRC Screening by FIT at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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) yielding a total score between 3 to 12. Higher summated scores indicate higher perceived benefits of screening by FIT.

  17. Perceived Barriers to CRC Screening by Colonoscopy [ Time Frame: Baseline interview ]
    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) yielding a total score between 16 to 64. Higher summated scores indicate higher perceived barriers to screening by colonoscopy.

  18. Change from Baseline in Perceived Barriers to CRC Screening by Colonoscopy at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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) yielding a total score between 16 to 64. Higher summated scores indicate higher perceived barriers to screening by colonoscopy.

  19. Perceived Barriers to CRC Screening by FIT [ Time Frame: Baseline interview ]
    Perceived barriers to FIT is measured by self-report using a a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) yielding a total score between 10 to 40. Higher summated scores indicate higher perceived barriers to screening by FIT.

  20. Change from Baseline in Perceived Barriers to CRC Screening by FIT at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in perceived barriers to FIT is measured by self-report using a a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) yielding a total score between 10 to 40. Higher summated scores indicate higher perceived barriers to screening by FIT.

  21. Perceived Self-Efficacy for CRC Screening by Colonoscopy [ Time Frame: Baseline interview ]
    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) yielding a total score between 11 to 44. Higher summated scores indicate higher perceived self-efficacy for CRC screening by colonoscopy.

  22. Change from Baseline in Perceived Self-Efficacy for CRC Screening by Colonoscopy at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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) yielding a total score between 11 to 44. Higher summated scores indicate higher perceived self-efficacy for CRC screening by colonoscopy.

  23. Perceived Self-Efficacy for CRC Screening by FIT [ Time Frame: Baseline interview ]
    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) yielding a total score between 7 to 28. Higher summated scores indicate higher perceived self-efficacy for CRC screening by FIT.

  24. Change from Baseline in Perceived Self-Efficacy for CRC Screening by FIT at 6 Months [ Time Frame: 6 months post-baseline interview ]
    Change from baseline in 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) yielding a total score between 7 to 28. Higher summated scores indicate higher perceived self-efficacy for CRC screening by FIT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200366


Locations
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United States, Indiana
Eskenazi Health
Indianapolis, Indiana, United States, 46202
Indiana University School of Nursing
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Patient-Centered Outcomes Research Institute
Ohio State University
Investigators
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Principal Investigator: Susan M Rawl, PhD,RN Indiana University

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Responsible Party: Susan Rawl, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03200366     History of Changes
Other Study ID Numbers: 1605880142
IHS-1507-31333 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A copy of the complete, cleaned, de-identified data set used to conduct the final analyses will be made available in the nine month period of the final year of funding (i.e., between September 1, 2020 to May 31, 2021). This de-identified data set will be available to other researchers upon written request to the the study's Principal Investigator, Dr. Susan Rawl.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Rawl, Indiana University:
Cancer Screening Tests
Colonoscopy

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases