Lung Non-Small Cell CarcinomaNCT06122064
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
A study testing Best Practice, Communication Intervention and Electronic Health Record Review in people with Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- What is being tested?
- Best Practice, Communication Intervention and Electronic Health Record Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Konstantinos Leventakos, M.D., Ph.D.
About this study
Official title: Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Being tested
- Best Practice, Communication Intervention, Electronic Health Record Review, Survey Administration, Video Recording
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Communication InterventionOther
Use shared decision-making conversation tool
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Video RecordingOther
Ancillary studies
Audio RecordingOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients attend a standard of care visit with their clinician on study. Receives: 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. Receives: Other: Best Practice; Other: Communication Intervention; Other: Electronic Health Record Review; Other: Survey Administration; Other: Video Recording; Other: Audio Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: After each encounter for the duration of the study, until accrual is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start20 Nov 2023
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantinos Leventakos, M.D., Ph.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122064
- Sponsor's protocol ID
- 23-003089
- Other IDs
- NCI-2023-07463, 23-003089
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 42183367
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06122064
- Acronym / sponsor ID
- 23-003089
- 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 type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Survey Administration, Other: Video Recording, Other: Audio RecordingPatients attend a standard of care visit with their clinician on study. |
| Arm II (standard of care, conversation aid) | Experimental | Other: Best Practice, Other: Communication Intervention, Other: Electronic Health Record Review, Other: Survey Administration, Other: Video Recording, Other: Audio RecordingPatients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (standard of care), Arm II (standard of care, conversation aid) |
| Communication InterventionUse shared decision-making conversation tool | Other | Arm II (standard of care, conversation aid) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, conversation aid) |
| Survey AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, conversation aid) |
| Video RecordingAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, conversation aid) |
| Audio RecordingAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, conversation aid) |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42183367Bandi 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos Leventakos, M.D., Ph.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Communication Intervention and Electronic Health Record Review in people with Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the intervention on implementing shared decision making (time frame: Baseline (immediately following appointment); 2 weeks post appointment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.