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Improving Rates of Repeat Colorectal Cancer Screening

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Northwestern University

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Behavioral: Reminder and Outreach Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01453894
1P01HS021141-01-Project1
1P01HS021141-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

450 patients

Sex

All

Ages

51 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

450 participants in 2 patient groups

Reminder and Outreach Intervention
Experimental group
Description:
Participants randomized to this arm will receive the Reminder and Outreach intervention.
Treatment:
Behavioral: Reminder and Outreach Intervention
Usual Care Control Group
No Intervention group
Description:
Patients assigned to this arm will receive usual care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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