An interventional study of Best Practice and Communication Intervention in Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
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.
PRIMARY OBJECTIVES:
I. Encounters where standard of care and the non-small cell lung cancer (NSCLC) choice conversation aid were utilized will have an improvement in the quality of the shared decision-making process over encounters with standard of care alone.
II. Patients with encounters where the NSCLC choice conversation aid was used along with standard of care will have decreased decisional conflict in regard to treatment choice compared to standard of care alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend a standard of care visit with their clinician on study.
ARM II: Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
After completion of study intervention, patients are followed up at 2 and 6 weeks.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients attend a standard of care visit with their clinician on study.
Other: Best Practice · Other: Electronic Health Record Review · Other: Survey Administration · Other: Video Recording · Other: Audio Recording
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
Other: Best Practice · Other: Communication Intervention · Other: Electronic Health Record Review · Other: Survey Administration · Other: Video Recording · Other: Audio Recording
Receive standard of care
Also known as: standard of care, standard therapy
Use shared decision-making conversation tool
Ancillary studies
Ancillary studies
Ancillary studies
Ancillary studies
Effectiveness of the intervention on implementing shared decision making
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.
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Degree of involvement of patients by the clinician in the shared decision making
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.
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Provider satisfaction with NSCLC choice conversation aid
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.
Time frame: After each encounter for the duration of the study, until accrual is reached
Knowledge transfer
Knowledge transfer will be assessed using 6 questions about treatment options to prevent recurrence of lung cancer. The 6 questions use a response format of "True / False / Do not know". Correct responses will be summed and divided by the total number of questions asked. If a patient answers at least 1 knowledge question then they will be assessed for this outcome, where all missing responses will be coded as incorrect.
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Patient satisfaction
Patient satisfaction with encounter will be assessed with 1 question on a 7-point Likert scale. Patients will be asked whether they would recommend the approach used to others for other discussions.
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Decisional conflict scale (DCS)
The 16 items of DCS are scored on a 0-4 scale where higher scores are reflective of uncertainty about treatment choice.
Time frame: Baseline (immediately following appointment); 2 weeks post appointment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Carcinoma, Non-Small-Cell Lung→
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