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Recruiting NCT06122064

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

No phase Interventional Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Communication Intervention, Electronic Health Record Review, Survey Administration.
Who it may be relevant to
Registry conditions: Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Publications

  • Bandi SSS, Branda ME, Chavez MM, Bagewadi S, Norman AS, Montori V, Gionfriddo MR, Hargraves IG, Boehmer K, Stephen A, Sagen C, Montori VM, Brito JP, Leventakos K. Encounter tool for Shared Decision Making about Adjuvant Treatment of Lung Cancer: Randomized Clinical Trial. Res Sq [Preprint]. 2026 May 11:rs.3.rs-8843093. doi: 10.21203/rs.3.rs-8843093/v1. PMID 42183367

Identifiers

NCT: NCT06122064 · 23-003089 · NCI-2023-07463 · 23-003089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗