Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
Summary
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.
Detailed description
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.
Arms & interventions
- OtherBest Practice
Receive standard of care
- OtherCommunication Intervention
Use shared decision-making conversation tool
- OtherElectronic Health Record Review
Ancillary studies
- OtherSurvey Administration
Ancillary studies
- OtherVideo Recording
Ancillary studies
- OtherAudio Recording
Ancillary studies
Outcome measures
Primary
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
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
References
- Bandi SSS, Branda ME, Chavez MM, Bagewadi S, Norman AS, Montori V, Gionfriddo MR, Hargraves IG, Boehmer K, Stephen A, Sagen C, Montori VM, Brito JP, Leventakos K. Encounter tool for Shared Decision Making about Adjuvant Treatment of Lung Cancer: Randomized Clinical Trial. Res Sq [Preprint]. 2026 May 11:rs.3.rs-8843093. doi: 10.21203/rs.3.rs-8843093/v1.(PubMed)