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

NCT06122064 | Recruiting

• 2 other identifiers: 23-003089NCI-2023-07463
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• Effectiveness of the intervention on implementing shared decision making

  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.

  Baseline (immediately following appointment); 2 weeks post appointment

• Degree of involvement of patients by the clinician in the shared decision making

  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.

  Baseline (immediately following appointment); 2 weeks post appointment

• Provider satisfaction with NSCLC choice conversation aid

  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.

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

Other Outcomes (3)

• Knowledge transfer

  Baseline (immediately following appointment); 2 weeks post appointment

• Patient satisfaction

  Baseline (immediately following appointment); 2 weeks post appointment

• Decisional conflict scale (DCS)

  Baseline (immediately following appointment); 2 weeks post appointment

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Electronic Health Record Review; Other: Survey Administration; Other: Video Recording; Other: Audio Recording

Arm II (standard of care, conversation aid)

EXPERIMENTAL

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

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

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (standard of care); Arm II (standard of care, conversation aid)

Communication Intervention OTHER

Use shared decision-making conversation tool

Arm II (standard of care, conversation aid)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (standard of care); Arm II (standard of care, conversation aid)

Survey Administration OTHER

Ancillary studies

Arm I (standard of care); Arm II (standard of care, conversation aid)

Video Recording OTHER

Ancillary studies

Arm I (standard of care); Arm II (standard of care, conversation aid)

Audio Recording OTHER

Ancillary studies

Arm I (standard of care); Arm II (standard of care, conversation aid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Videotape Recording; Sound Recordings

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

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

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 8, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)