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

NCT ID: NCT06122064

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (standard of care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Video Recording

Intervention Type OTHER

Ancillary studies

Audio Recording

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive standard of care

Communication Intervention

Intervention Type OTHER

Use shared decision-making conversation tool

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Video Recording

Intervention Type OTHER

Ancillary studies

Audio Recording

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Communication Intervention

Use shared decision-making conversation tool

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Video Recording

Ancillary studies

Intervention Type OTHER

Audio Recording

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2023-07463

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-003089

Identifier Type: OTHER

Identifier Source: secondary_id

23-003089

Identifier Type: -

Identifier Source: org_study_id

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