Clinical trial NCT06122064: A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
Official title: Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effectiveness of the intervention on implementing shared decision making
timeFrame: Baseline (immediately following appointment); 2 weeks post appointment
measure: Degree of involvement of patients by the clinician in the shared decision making
timeFrame: Baseline (immediately following appointment); 2 weeks post appointment
measure: Provider satisfaction with NSCLC choice conversation aid
timeFrame: After each encounter for the duration of the study, until accrual is reached
Secondary outcomes:
Other outcomes:
measure: Knowledge transfer
timeFrame: Baseline (immediately following appointment); 2 weeks post appointment
measure: Patient satisfaction
timeFrame: Baseline (immediately following appointment); 2 weeks post appointment
measure: Decisional conflict scale (DCS)
timeFrame: Baseline (immediately following appointment); 2 weeks post appointment
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Konstantinos Leventakos, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: