Evidence Based Colorectal Cancer Screening for the Uninsured - Sub-study

NCT02651974 | Completed

• 1 other identifier: 082012-086 Sub-study
• Study Type: interventional
• Target: 8,565
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a sub-study nested within a previously initiated clinical study (# NCT01946282) focusing on individuals not previously randomized at baseline to the original interventions. The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3 strategies for promoting screening completion among individuals not up to date with colorectal cancer screening, but assigned to receive screening outreach.

Conditions

Colorectal Cancer

Keywords

neoplasm; colorectal; cancer; uninsured; FIT; fecal immunochemical test

Outcome Measures

Primary Outcomes (1)

• Percentage of individuals who complete FIT screening measured by return FIT kit

  The primary outcome will be analyzed using an intention to treat approach. An "a priori" estimated sample size is 2,124; assigned 1:1:1 via simple randomization, stratified by round of invitation to each of the three intervention groups. Sample size was constrained by the number of individuals eligible for screening outreach; all eligible individuals during study period will be included in one of the intervention groups. Assuming a standard intervention group FIT completion rate of 36%, and two-sided alpha=0.125 for each comparison, an estimated 80% power to detect a \>8% difference between Condition 1 (standard mailed invitation, n=708) and Condition 2 (n=708), as well as 80% power to detect a \>8% difference between Condition 1 (n=708) and Condition 3 (n=708).

  Within 3 months of invitation

Secondary Outcomes (4)

• Percentage of individuals who receive a positive (abnormal) FIT result that then call to receive additional information about potential follow-up test.

  Within 6 months of mailed FIT results letter

• Percentage of individuals who schedule a pre-operative clinic visit (if recommended).

  Within 6 months of mailed FIT results letter

• Percentage of individuals who complete a colonoscopy (if recommended).

  Within 6 months of mailed FIT results letter

• Pre-post analysis of current results reporting strategy (which will utilize a white envelope for normal results, and a red envelope for abnormal results) to prior generic envelope for FIT result reporting for both normal and abnormal results.

  Within 6 months of mailed FIT results letter

Study Arms (3)

Control condition

ACTIVE COMPARATOR

A control invitation letter similar to the previous standard (non-incentive) invitation with slight wording and grammatical improvements will be mailed to patients randomly assigned to this group.

Behavioral: Cost condition; Behavioral: Cost/Future condition

Cost condition

ACTIVE COMPARATOR

A control invitation letter with the addition of one line informing participants of the average value of the KIT procedure will be mailed to patients randomly assigned to this group.

Behavioral: Control condition; Behavioral: Cost/Future condition

Cost/Future condition

ACTIVE COMPARATOR

An invitation letter with the average value of the KIT procedure and a sentence assuring participants that should a follow-up test be requested, it will also be provided free of charge will be mailed to patients randomly assigned to this group.

Behavioral: Control condition; Behavioral: Cost condition

Interventions

Control condition BEHAVIORAL

Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost condition; Cost/Future condition

Cost condition BEHAVIORAL

Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Control condition; Cost/Future condition

Cost/Future condition BEHAVIORAL

Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Control condition; Cost condition

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Uninsured
• Participants in John Peter (JPS) Health System medical assistance program for the uninsured.
• One or more visits to a JPS primary care clinic within a year.
• Not up-to-date with colorectal cancer screening

You may not qualify if:

• Patients with a history of colorectal cancer or colon resection
• No address and/or phone number on file with JPS
• Incarcerated

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Keith E Argenbright, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: January 11, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 25, 2020

Record last verified: 2020-02