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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122064
• Other study ID #: 23-003089
• Secondary ID: NCI-2023-0746323
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Best Practice
Receive standard of care
• Communication Intervention
Use shared decision-making conversation tool
• Electronic Health Record Review
Ancillary studies
• Survey Administration
Ancillary studies
• Video Recording
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline (immediately following appointment); 2 weeks post appointment
Other	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
Other	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
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.	Baseline (immediately following appointment); 2 weeks post appointment
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials