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

Mayo Clinic

Status: Enrolling

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

Treatments: Other: Electronic Health Record Review; Other: Video Recording; Other: Best Practice; Other: Survey Administration; Other: Communication Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06122064

23-003089 (Other Identifier)

NCI-2023-07463 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm I (standard of care)

Active Comparator group

Description:

Patients attend a standard of care visit with their clinician on study.

Treatment:

Other: Electronic Health Record Review

Other: Best Practice

Other: Survey Administration

Other: Video Recording

Arm II (standard of care, conversation aid)

Experimental group

Description:

Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.

Treatment:

Other: Communication Intervention

Other: Electronic Health Record Review

Other: Best Practice

Other: Survey Administration

Other: Video Recording