Improving Rates of Repeat Colorectal Cancer Screening

Colorectal Neoplasms Clinical Trial

Official title:

Center for Advancing Equity in Clinical Preventive Services Project 1: Improving Rates of Repeat Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453894
• Other study ID #: 1P01HS021141-01-Project1
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: July 24, 2014
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations.

Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT).

Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period

Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date.

Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period.

Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months

Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 75 Years

Eligibility

Inclusion Criteria:

• Fecal occult blood test (FOBT) completed in the past year

• Age 51-75

• Preferred language English or Spanish

Exclusion Criteria:

• Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date

• Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Behavioral:
• Reminder and Outreach Intervention
This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of a Fecal Occult Blood Test (FOBT)	This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.	within 6 months of randomization	No