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Completed

NCT Number: NCT03819920

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: CCRAT

Usual care (UC)

Behavioral

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

Other names: UC

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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