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Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

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ClinicalTrials.gov Identifier: NCT03819920
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Uri Ladabaum, Stanford University

Brief Summary:
This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Risk Assessment (CCRAT) Behavioral: Usual Care (UC) Not Applicable

Detailed Description:
Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Actual Study Start Date : October 6, 2015
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : January 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Usual Care (UC)
Patients receive standardized general information about colorectal cancer screening over the telephone.
Behavioral: Usual Care (UC)
Patients receive standardized general information about colorectal cancer screening over the telephone.
Other Name: UC

Active Comparator: Risk Assessment (CCRAT)
Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)
Behavioral: Risk Assessment (CCRAT)
Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)
Other Name: CCRAT

Behavioral: Usual Care (UC)
Patients receive standardized general information about colorectal cancer screening over the telephone.
Other Name: UC




Primary Outcome Measures :
  1. Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT [ Time Frame: 12 months after intervention ]
    Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)


Secondary Outcome Measures :
  1. Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT [ Time Frame: 6 months after intervention ]
    Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)

  2. Change in intention to screen at 6 months and 12 months [ Time Frame: Immediate after intervention, 6 months and 1 year after intervention ]
    Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.

  3. Colorectal cancer screening rates at 12 months as a function of CCRAT score [ Time Frame: 12 months after intervention ]
    Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion


Other Outcome Measures:
  1. Risk perception: Health Belief Model Likert Scale [ Time Frame: Immediate after intervention ]
    Differences in perception of one's own risk of colorectal cancer ranging from "very unlikely" (minimum) to "very likely" (maximum), with "very unlikely" representing the most favorable outcome of perceived risk and "very likely" representing the most unfavorable outcome of perceived risk.

  2. Fear: Health Belief Model Likert Scale [ Time Frame: Immediate after intervention ]
    Presence of fear of discovering colorectal cancer on performing screening test ranging from "strongly disagree" (minimum) to "strongly agree" (maximum), with "strongly disagree" representing the most favorable outcome of fear and "strongly agree" representing the most unfavorable outcome of fear.



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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:

  • Patient of any participating physician
  • Not having had any colorectal cancer screening test prior
  • Able to speak English

Exclusion Criteria:

  • Personal history of inflammatory bowel disease
  • Personal history of colorectal cancer
  • Personal history of Lynch syndrome or Familial Adenomatous Polyposis
  • Have already received colorectal cancer screening

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): NCT03819920


Locations
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United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Uri Ladabaum, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Uri Ladabaum, Stanford University:
Informed Consent Form  [PDF] November 21, 2018


Additional Information:
Publications:
American Cancer Society. Cancer Facts and Figures 2014. Atlanta, GA: American Cancer Society; 2014.
American Cancer Society. Colorectal Cancer Facts and Figures, 2014-2016. Atlanta, GA: American Cancer Society; 2014.
Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2010. Bethesda, MD: National Cancer Institute, 2013.

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Responsible Party: Uri Ladabaum, Professor of Medicine, Director GI Cancer Prevention Program, Stanford University
ClinicalTrials.gov Identifier: NCT03819920     History of Changes
Other Study ID Numbers: IRB-32815
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Stanford Medicine Box) that is password protected
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2/1/2019-2/1/2021
Access Criteria: Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Uri Ladabaum can submit a request.

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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 Uri Ladabaum, Stanford University:
cancer screening beliefs
colorectal cancer screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases