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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07517692 on ClinicalTrials.gov