Clinical trial NCT03819920: Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Official title: Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer screening beliefs
colorectal cancer screening
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 229
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
timeFrame: 6 months after intervention
measure: Change in intention to screen at 6 months and 12 months
timeFrame: Immediate after intervention, 6 months and 1 year after intervention
measure: Colorectal cancer screening rates at 12 months as a function of CCRAT score
timeFrame: 12 months after intervention
Other outcomes:
measure: Risk perception: Health Belief Model Likert Scale
timeFrame: Immediate after intervention
measure: Fear: Health Belief Model Likert Scale
timeFrame: Immediate after intervention
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Uri Ladabaum, MD
role: PRINCIPAL_INVESTIGATOR
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