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

NCT03819920 | Completed

• 1 other identifier: IRB-32815
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

cancer screening beliefs; colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT

  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)

  12 months after intervention

Secondary Outcomes (3)

• Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT

  6 months after intervention

• Change in intention to screen at 6 months and 12 months

  Immediate after intervention, 6 months and 1 year after intervention

• Colorectal cancer screening rates at 12 months as a function of CCRAT score

  12 months after intervention

Other Outcomes (2)

• Risk perception: Health Belief Model Likert Scale

  Immediate after intervention

• Fear: Health Belief Model Likert Scale

  Immediate after intervention

Study Arms (2)

Usual Care (UC)

PLACEBO COMPARATOR

Patients receive standardized general information about colorectal cancer screening over the telephone.

Behavioral: Usual Care (UC)

Risk Assessment (CCRAT)

ACTIVE COMPARATOR

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); Behavioral: Usual Care (UC)

Interventions

Risk Assessment (CCRAT) BEHAVIORAL

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)

Also known as: CCRAT

Risk Assessment (CCRAT)

Usual Care (UC) BEHAVIORAL

Patients receive standardized general information about colorectal cancer screening over the telephone.

Also known as: UC

Risk Assessment (CCRAT); Usual Care (UC)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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• Yen T, Qin F, Sundaram V, Asiimwe E, Storage T, Ladabaum U. Randomized Controlled Trial of Personalized Colorectal Cancer Risk Assessment vs Education to Promote Screening Uptake. Am J Gastroenterol. 2021 Feb 1;116(2):391-400. doi: 10.14309/ajg.0000000000000963.

  PMID: 33009045 DERIVED

Related Links

• National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Uri Ladabaum, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director GI Cancer Prevention Program

Model Details: 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)

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: October 6, 2015
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)