Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening
NCT07517692 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-05-14
Summary
The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:
* Does the patient and provider support increase the number of patients who complete lung cancer screening?
* Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?
* Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.
Primary care provider participants will:
* Receive the provider support session and educational materials, or follow usual practice
* Answer a baseline survey and a follow-up survey in 6 months
* Answer additional survey questions regarding the acceptability of the provider support session if they receive it
Patient participants will
* Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care
* Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.
Conditions
- Lung Cancer Screening
Interventions
- BEHAVIORAL
-
FIX-SDM
Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
- BEHAVIORAL
-
Usual Care
PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Massachusetts, Worcester
lead OTHER
Principal Investigators
-
Mayuko Ito Fukunaga, MD, MSc · UMass Chan Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 77 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-07
- Primary Completion
- 2028-01-01
- Completion
- 2028-03-01
Countries
- United States
Study Locations
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