A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial

Conditions
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Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

Intervention / Treatment
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* Other: Best Practice
* Other: Communication Intervention
* Other: Electronic Health Record Review
* Other: Survey Administration
* Other: Video Recording


Participation Criteria
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Eligibility Criteria
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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]) PATIENTS: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care)<br>Patients attend a standard of care visit with their clinician on study. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Video Recording<br>* Ancillary studies<br>|
| Experimental: Arm II (standard of care, conversation aid)<br>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<br>* Receive standard of care<br>* Other names: standard therapy;Other: Communication Intervention<br>* Use shared decision-making conversation tool<br>Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>Other: Video Recording<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | After each encounter for the duration of the study, until accrual is reached |