Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06122064

Conditions

Lung Non-Small Cell Carcinoma

Stage II Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Communication Intervention

Electronic Health Record Review

Survey Administration

Video Recording

Study Details

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.

Conditions

Lung Non-Small Cell Carcinoma

Stage II Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Stage IV Lung Cancer AJCC v8

Study ID

NCT06122064

Start date

Nov 20, 2023

Status verified date

Aug, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Arm I (standard of care)

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

experimental: Arm II (standard of care, conversation aid)

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

Interventions

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

Audio Recording

Ancillary studies

Primary outcome measure

  • Effectiveness of the intervention on implementing shared decision making [ Time Frame: Baseline (immediately following appointment); 2 weeks post appointment ]
  • Degree of involvement of patients by the clinician in the shared decision making [ Time Frame: Baseline (immediately following appointment); 2 weeks post appointment ]
  • Provider satisfaction with NSCLC choice conversation aid [ Time Frame: After each encounter for the duration of the study, until accrual is reached ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Konstantinos Leventakos, M.D., Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-20.