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Study identifier: NCT06682650 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Implementation of a ColoRectal Cancer Screening Tool in US Primary Care Practices - Usual Quality Improvement (10 Clinics) vs Normalization Process Theory-Participatory Learning in Action (10 Clinics)

Condition: Colorectal Carcinoma  ·  Sponsor: University of Kansas Medical Center

PhaseNA
Planned participants2200
Who can joinAll sexes, 45 Years to 75 Years
Healthy volunteersYes

About this study

Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participati…

This description comes directly from the study's public registry record.

Talk to the study team

Joseph W LeMaster, MD MPH  ·  573-999-3366  ·  jlemaster@kumc.edu

Traci Buechner  ·  715-661-2422  ·  tbuechner@kumc.edu

Always discuss trial participation with your own doctor first.

Locations (1)

DARTNet InstituteAurora, Colorado, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06682650