Clinical trial · Interventional
Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIX-SDM | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FIX-SDM
- description
- 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.
- interventionNames
- Behavioral: FIX-SDM
- type
- ACTIVE_COMPARATOR
- label
- Comparator: Usual Care
- description
- PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care.
- interventionNames
- Behavioral: Usual Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available