Reminder Modality for CRC Screening

Colorectal Cancer Clinical Trial

Official title:

Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012007
• Other study ID #: FIT2
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: April 26, 2022

Study information

• Verified date: May 2022
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.

Description:

This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening.

Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions:

1. Control arm: No reminder

a. Intervention Type: No intervention

2. Arm 2: Automated phone reminder

a. Intervention Type: Standard reminder via phone (audiocare)

3. Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2653
• Est. completion date: April 26, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion Criteria:

• Veterans assigned to a primary care provider at the VA Puget Sound as of January 1, 2021

• At least 1 year of prior data available (evidence of at least one outpatient visit).

• Due for annual CRC screening

Exclusion Criteria:

• Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.

• No indication of current receipt of hospice care or record of recent death in the administrative data.

• No personal history of CRC or history of prior colectomy.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Reminder Phone
Standard reminder via phone (audiocare)
• Reminder Text
reminder via text (VEText)

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interim analysis	z-statistic will be calculated from the proportional difference between the combined treatment groups (all reminders) vs. control	At 50% (n = 1327) of estimated sample size
Primary	Percentage of returned FIT Kits	the return rate at three months post randomization	three months post randomization
Secondary	Percentage of returned FIT Kits	the return rate at six months post randomization	six months post randomization