Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06122064

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lung Non-Small Cell Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

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

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Communication intervention

Other

Use shared decision-making conversation tool

Electronic Health Record Review

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Video recording

Other

Ancillary studies

Audio Recording

Other

Ancillary studies

Primary outcomes

  1. Effectiveness of the intervention on implementing shared decision making

    Time frame: Baseline (immediately following appointment); 2 weeks post appointment

    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.

  2. Degree of involvement of patients by the clinician in the shared decision making

    Time frame: Baseline (immediately following appointment); 2 weeks post appointment

    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.

  3. Provider satisfaction with NSCLC choice conversation aid

    Time frame: After each encounter for the duration of the study, until accrual is reached

    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.

Other outcomes

  1. Knowledge transfer

    Time frame: Baseline (immediately following appointment); 2 weeks post appointment

    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.

  2. Patient satisfaction

    Time frame: Baseline (immediately following appointment); 2 weeks post appointment

    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.

  3. Decisional conflict scale (DCS)

    Time frame: Baseline (immediately following appointment); 2 weeks post appointment

    The 16 items of DCS are scored on a 0-4 scale where higher scores are reflective of uncertainty about treatment choice.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.