FIX-SDM Program for Lung Cancer Screening

(FIX-SDM LCS Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MI

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

* Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
* Who care for more than 5 potentially LCS-eligible patients in their practice
* PCPs (physicians or advanced practitioners)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the FIX-SDM support program or usual care, including surveys and educational materials

3 months
Baseline survey, primary care visit, follow-up surveys

Follow-up

Participants are monitored for completion of lung cancer screening and decision-making outcomes

6 months
Surveys at 3 and 6 months

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

Group I: FIX-SDMExperimental Treatment1 Intervention
Group II: Comparator: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

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 ...