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?
This trial tests a new support program called FIX-SDM, designed to help patients and healthcare providers make better decisions together about lung cancer screening. The trial aims to determine if this program increases the number of people completing their lung cancer screenings. It will compare this approach to regular care to assess improvements in decision-making and screening rates. Individuals who currently smoke or quit smoking within the last 15 years, have a history of smoking at least 20 pack-years, and have an upcoming doctor's visit might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in healthcare decision-making.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on lung cancer screening and decision-making support, so it's unlikely that your current medications would be affected.
What prior data suggests that the FIX-SDM program is safe for lung cancer screening?
In a previous study, participants who engaged in shared decision-making for lung cancer screening felt more comfortable discussing their screening results with their doctors. This finding indicates that the FIX-SDM program, which includes educational materials and support sessions, is generally well-received by both patients and healthcare providers. No reports of negative effects linked to the support program itself emerged. By focusing on communication and decision-making, this type of program carries minimal risk to participants. Overall, available research suggests that the FIX-SDM program is safe for participants.12345
Why are researchers excited about this trial?
Researchers are excited about the FIX-SDM program because it aims to improve lung cancer screening by enhancing the decision-making process for both patients and primary care providers. Unlike the usual care, which primarily relies on standard e-alert notifications, FIX-SDM provides additional educational support, a smoking history survey, and text message reminders to better prepare patients for their primary care visits. This proactive approach is designed to engage patients more effectively and facilitate shared decision-making, potentially leading to earlier detection and improved outcomes in lung cancer screening.
What evidence suggests that the FIX-SDM program is effective for increasing lung cancer screening?
Studies have shown that shared decision-making (SDM) can significantly improve outcomes in lung cancer screening. Research indicates that an enhanced SDM process helps patients better understand screening, reduces decision-making stress, and increases their willingness to undergo screenings. Specifically, programs incorporating SDM have demonstrated a small but clear increase in the number of individuals screened for lung cancer. For instance, programs involving both patients and doctors can double the likelihood of patients completing lung cancer screenings. This trial will test the FIX-SDM program, where primary care providers receive additional support and educational materials to enhance SDM. Overall, SDM tools assist patients by making the screening process easier to understand and more acceptable.24567
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?
This trial is for primary care providers (doctors or advanced practitioners) at UMass Memorial Health who work in general internal medicine or family medicine and see more than 5 patients eligible for lung cancer screening. Their patients may also be involved if they are considering lung cancer screening.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
Trial Overview
The study compares usual care to a support program called FIX-SDM, which gives both patients and providers extra information and tools to help them make decisions together about lung cancer screening during regular doctor visits.
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
Citations
FIX-SDM Program for Lung Cancer Screening
The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and ...
Impact of the shared decision‐making process on lung cancer ...
This study found that a better SDM process was associated with greater knowledge of LCS, less decisional conflict, and intentions to adhere to LCS screening ...
Shared Decision-Making for Lung Cancer Screening
To assess “effectiveness” of SDM overall, we also assessed CoE for studies of any SDM versus usual care (concurrent or pre-post comparisons) ...
Effectiveness of interventions for increasing lung cancer ...
Overall, interventions showed a modest but significant effect on LCS uptake (RR = 1.34; 95 % CI: 1.02, 1.76). The multi-component intervention (RR = 2.11; 95 % ...
Doctor-led Shared Decision-Making Significantly Boosts ...
found just 22.3% repeated screening after one year and less than 5.9% by year three. The Neiman Institute researchers found that 34.8% of ...
Facilitation of Information eXchange for Shared Decision ...
Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
Improving lung cancer screening in real-world settings - PMC
The percentage of PCPs that felt “very comfortable” and “somewhat comfortable” discussing the results of LDCT with their patients increased from 45.9% of ...
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