FIX-SDM Program for Lung Cancer Screening
(FIX-SDM LCS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Mayuko Ito Fukunaga, MD, MSc
Principal Investigator
UMass Chan Medical School
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the FIX-SDM support program or usual care, including surveys and educational materials
Follow-up
Participants are monitored for completion of lung cancer screening and decision-making outcomes
What Are the Treatments Tested in This Trial?
Interventions
- FIX-SDM
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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 will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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