Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening

Plain English Summary

Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening is a Not Applicable clinical trial sponsored by University of Massachusetts, Worcester studying Lung Cancer Screening. This study tests a program called FIX-SDM designed to improve how patients and their doctors discuss and decide on lung cancer screening. It is for adults aged 50-77 who currently smoke or quit recently, have a significant smoking history, and are eligible for lung cancer screening. Participants will receive information and support about lung cancer screening before and during their doctor's visit, or they will receive standard care. The main alternative is to rely on current standard practices for discussing and deciding on lung cancer screening with a doctor. The trial aims to enroll 120 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are an adult aged 50-77, have a history of smoking (20+ pack-years, quit within 15 years), are eligible for lung cancer screening, have a smartphone, speak English, and have a doctor's appointment coming up. You cannot join if you have already had lung cancer screening, had a chest CT scan in the last year, have a history of lung cancer, are being treated for active cancer, use supplemental oxygen, are pregnant, or were part of the initial development of this program. Doctors who practice general internal medicine or family medicine at UMass Memorial Health and care for patients eligible for lung cancer screening can participate. This trial is studying Lung Cancer Screening, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures whether the program helps more patients complete lung cancer screening within 3 months of their doctor's visit, meaning it aims to make sure more people who could benefit The specific primary outcome measures are: Completion of Lung Cancer Screening (LCS) within 3 months (3 months after the index visit). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to improve shared decision-making for lung cancer screening, potentially increasing the number of eligible patients who get screened and fill a gap in ensuring patie This research targets Lung Cancer Screening, where improved treatment options are needed.

Investor Insight

This pilot study by the University of Massachusetts signals a focus on improving patient-provider communication for a critical screening test, with potential for broader adoption if successful, impact

Is This Trial Right for Me?

Ask your doctor if lung cancer screening is right for you and what the benefits and risks are. Understand what information you will receive before and after your doctor's visit regarding lung cancer screening. Be prepared to answer surveys about your smoking history and your decision-making process. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 120 participants

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

Primary Outcomes

• Completion of Lung Cancer Screening (LCS) within 3 months (3 months after the index visit)

Secondary Outcomes

• Completion of LCS within 6 months (6 months after the index visit)
• LCS order (3 and 6 months after the index visit)
• LCS appointment (3 and 6 months after the index visit)
• Patient-reported LCS discussion (Within 10 days after the index visit)
• Content of LCS discussion (Within 10 days after the index visit)

Full Eligibility Criteria

Primary care provider (PCP) participants:

Inclusion criteria

* PCPs (physicians or advanced practitioners)
* 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 Exclusion criteria
* Participation in the previous study to co-develop the provider intervention (to avoid bias)

Patient participants

Inclusion Criteria:

* Adults between the ages of 50 and 77
* Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
* Has a smartphone with texting capability
* English-speaking
* Has a scheduled PCP visit in the next \~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study

Exclusion Criteria:

* Prior LCS
* Chest CT within the last 12 months
* History of lung cancer
* Active cancer requiring treatment
* Supplemental oxygen use
* Pregnancy
* Participation in the previous study to co-develop the patient intervention (to avoid bias)

Trial Locations

• University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Lung Cancer Screening
• Smoking Cessation
• Primary Care
• Shared Decision Making
• Preventive Medicine
• Health Communication
• Patient Education
• Clinical Trial Feasibility
• Medical Decision Making

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