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Information With or Without Numbers For Optimizing Reasoning About Medical Decisions (INFORM)

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ClinicalTrials.gov Identifier: NCT02477553
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Peter Schwartz, Indiana University

Brief Summary:

Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.

The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Behavioral: DA - Quantitative Behavioral: DA - Verbal Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 728 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information
Study Start Date : June 2015
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quantitative

Subjects view:

  1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
  2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Behavioral: DA - Quantitative
Active Comparator: Verbal

Subjects view:

  1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
  2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
Behavioral: DA - Verbal



Primary Outcome Measures :
  1. Self-report CRC screening completion with medical record verification of screening test completion [ Time Frame: 6 months post intervention ]
    Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on self-report and medical record verification.

  2. Self-report CRC screening intention [ Time Frame: 1 day ]
    Multiple choice questions assessing subject's intention in getting a CRC screening test in the next 6 months and a single question assessing subject's preferred test.


Secondary Outcome Measures :
  1. Self-report perceived risk of CRC [ Time Frame: 1 day ]
    Multiple choice questions assessing subject's perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime; One multiple choice question assessing subject's perceived age and gender-adjusted comparative risk. Two items assessing subject's perceived likelihood of getting CRC if they do and do not have regular colon testing.

  2. Self-report perceived benefits of CRC screening with FIT and colonoscopy [ Time Frame: 1 day ]
    Assessed separately for colonoscopy and FIT, using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items are measured using a 5-point Likert scale.

  3. Self-report perceived barriers to CRC screening with FIT or colonoscopy [ Time Frame: 1 day ]
    Assessed separately for colonoscopy and FIT, using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items are measured using a 5-point Likert scale.

  4. Knowledge of CRC and screening as measured by questionnaire [ Time Frame: 1 day ]
    Qualitative knowledge is assessed with multiple choice and True/False questions regarding general information (including risk factors, screening test options, and test frequency). Quantitative knowledge is assessed with multiple choice questions regarding the probability of outcomes related to CRC screening.

  5. Decision conflict as measured by the Decision Conflict Scale [ Time Frame: 1 day ]
    Decision conflict is assessed using the16-item Decision Conflict Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year and
  2. have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites.

Exclusion Criteria:

  1. undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
  2. have a diagnosis or medical history conferring elevated risk for CRC including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC
  3. are unable to speak and read English.

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): NCT02477553


Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 462020
Sponsors and Collaborators
Indiana University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Peter H Schwartz, M.D., Ph.D Indiana University

Responsible Party: Peter Schwartz, Assistant Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT02477553     History of Changes
Other Study ID Numbers: 1502774679
CDR-1403-11040 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Peter Schwartz, Indiana University:
decision aid
cancer screening
colorectal neoplasm
decision making
risk communication
numeracy
health literacy

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