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OpenTrials
Completed

NCT Number: NCT05012007

Reminder Modality for CRC Screening

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

About this study

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:

  • Control arm: No reminder

a. Intervention Type: No intervention

  • Arm 2: Automated phone reminder

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

  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reminder Phone

Other

Standard reminder via phone (audiocare)

Reminder Text

Other

reminder via text (VEText)

Primary outcomes

  1. Percentage of returned FIT Kits

    Time frame: three months post randomization

    the return rate at three months post randomization

Secondary outcomes

  1. Percentage of returned FIT Kits

    Time frame: six months post randomization

    the return rate at six months post randomization

Other outcomes

  1. Interim analysis

    Time frame: At 50% (n = 1327) of estimated sample size

    z-statistic will be calculated from the proportional difference between the combined treatment groups (all reminders) vs. control

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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