NCT06122064 · Mayo Clinic
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
What this study is about
This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options.
View original scientific description
This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.
Interventions
OTHER
Best Practice
Receive standard of care
OTHER
Communication Intervention
Use shared decision-making conversation tool
OTHER
Electronic Health Record Review
Ancillary studies
OTHER
Survey Administration
Ancillary studies
OTHER
Video Recording
Ancillary studies
OTHER
Audio Recording
Ancillary studies
Primary outcome measures
Effectiveness of the intervention on implementing shared decision making
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Effectiveness of the intervention will be assessed using the 9-item Shared Decision Making Questionnaire (SDMQ-9) to evaluate standard of care alone versus using the non-small cell lung cancer (NSCLC) conversation aid plus standard of care. The overall score is the sum of the 9 items, where lower values indicate less perceived shared decision making, and higher scores indicate more perceived shared decision making. Self-reported responses from patients and clinicians will also be collected at multiple timepoints throughout the study.
Degree of involvement of patients by the clinician in the shared decision making
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Evaluated using the 12-item "observing patient involvement" (OPTION12) tool, where reviewers will view and score recorded encounters. The survey tool consists of 12 items scored from 0-4, where 0=no effort and 4=exemplary effort.
Provider satisfaction with NSCLC choice conversation aid
Time frame: After each encounter for the duration of the study, until accrual is reached
Provider satisfaction with each encounter will be assessed with two questions. The first will be answered using a 5-point Likert scale where 1=Not at all satisfied and 5=Completely satisfied. The second will be answered using a 7-point scale where 1=No, I would strongly recommend against it and 7=Yes, I would strongly recommend it. Higher overall scores indicate higher satisfaction with the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- CLINICIANS:
- All clinicians within identified departments participating are eligible (doctor of medicine \[MD\]/doctor of osteopathy \[DO\], fellows/residents, physician assistant \[PA\]/nurse practitioner \[NP\])
- Adult patients (\>= 18 years of age)
- Appointments at Mayo Clinic in Rochester
- Non-small cell lung cancer (NSCLC) stage \> 1B
- Eligible by their oncologist for adjuvant treatment
Exclusion criteria
- Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)
Where
- Rochester, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations