NCT04923646

Brief Summary

This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,404

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

May 19, 2021

Last Update Submit

January 5, 2024

Conditions

Colorectal Cancer

Keywords

Cancer screeningBehavioral economicsAdherence

Outcome Measures

Primary Outcomes (1)

  • Return proportion

    Percent of returned FIT tests

    3 months

Secondary Outcomes (1)

  • Return proportion

    6 months

Study Arms (2)

Active

EXPERIMENTAL

Primer

Other: Primer

Control

NO INTERVENTION

No Primer

Interventions

PrimerOTHER

Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

Active

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • 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 colorectal (CRC) screening

You may not qualify if:

  • Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
  • Not currently receiving hospice care
  • No record of recent death in the administrative data.
  • No history of CRC or history of prior colectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

DNA Primers

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

OligodeoxyribonucleotidesOligonucleotidesPolynucleotidesNucleotidesNucleic Acids, Nucleotides, and NucleosidesDNA ProbesNucleic Acid ProbesMolecular ProbesLaboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Ashok Reddy, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

  • Stefanie Deeds, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 11, 2021

Study Start

June 30, 2021

Primary Completion

January 1, 2022

Study Completion

January 19, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)