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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07463 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-003089 | Other Identifier | Mayo Clinic in Rochester |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care) | Active Comparator | Patients attend a standard of care visit with their clinician on study. |
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| Arm II (standard of care, conversation aid) | Experimental | Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
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| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Leventakos, M.D., Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42183367 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Communication Intervention | Other | Use shared decision-making conversation tool |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Video Recording | Other | Ancillary studies |
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| Audio Recording | Other | Ancillary studies |
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| 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. | 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. | Baseline (immediately following appointment); 2 weeks post appointment |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D014743 | Videotape Recording |
| D000087983 | Sound Recordings |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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