Lung Non-Small Cell CarcinomaNCT05416983
Developing a Shared Decision Making Tool for Patients With Surgically Removed Non-small Cell Lung Cancer
An observational study of Lung Non-Small Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. 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
- What is being tested?
- Discussion and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with resected non-small cell lung cancer, clinicians, and PAG members.
Who may be able to join
- PATIENTS:
- Adults >= 18 years with biopsy proven resected non-small cell lung cancer (NSCLC)
- Appointments to discuss adjuvant treatment of resected NSCLC
- CLINICIANS:
- Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC
- PAG MEMBERS:
- Adults >= 18 years
- Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)
Who cannot join
- PATIENTS
- Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients With Resected Non-Small Cell Lung Cancer
This study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. Patients who have undergone surgery for their non-small cell lung cancer may have the option of completing additional treatment. Patients contemplating this additional treatment have been shown to be most satisfied with their choice if they perceive an effort by their doctor to share decision making. Shared decision making tools can help doctors guide conversations, offer tailored recommendations, and support deliberation on whether or not to pursue treatment. This study develops a shared decision making tool for patients with surgically removed non-small cell lung cancer contemplating additional treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected non-small cell lung cancer (NSCL) (NSCL adjuvant choice).
OUTLINE:
Patient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire.
- Conditions
- Lung Non-Small Cell Carcinoma
- Being tested
- Discussion, Questionnaire Administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionProcedure or surgery
Attend discussion
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (discussion) | Patient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire. Receives: Procedure: Discussion; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of decision aid
Measured: Up to study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start17 Feb 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konstantinos Leventakos, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416983
- Sponsor's protocol ID
- 21-013359
- Other IDs
- NCI-2022-01685
- Status last verified
- Oct 2025
- First submitted
- 6 Jun 2022
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients With Resected Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05416983
- Acronym / sponsor ID
- 21-013359
- Conditions
- Lung Non-Small Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Jun 2022 (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 study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. Patients who have undergone surgery for their non-small cell lung cancer may have the option of completing additional treatment. Patients contemplating this additional treatment have been shown to be most satisfied with their choice if they perceive an effort by their doctor to share decision making. Shared decision making tools can help doctors guide conversations, offer tailored recommendations, and support deliberation on whether or not to pursue treatment. This study develops a shared decision making tool for patients with surgically removed non-small cell lung cancer contemplating additional treatment.
Detailed description
PRIMARY OBJECTIVE:
- To develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected non-small cell lung cancer (NSCL) (NSCL adjuvant choice).
OUTLINE:
Patient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (discussion) | – | Procedure: Discussion, Other: Questionnaire AdministrationPatient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resected non-small cell lung cancer, clinicians, and PAG members.
Key inclusion criteria (8 listed)
- PATIENTS:
- Adults >= 18 years with biopsy proven resected non-small cell lung cancer (NSCLC)
- Appointments to discuss adjuvant treatment of resected NSCLC
- CLINICIANS:
- Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC
Key exclusion criteria (2 listed)
- PATIENTS
- Major barriers to providing informed consent (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 |
|---|---|---|
| DiscussionAttend discussion | Procedure or surgery | Observational (discussion) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (discussion) |
Primary outcome
Development of decision aid
Time frame: Up to study completion, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Lung Non-Small Cell Carcinoma
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. This study is not recruiting at the moment.
Konstantinos Leventakos, M.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?
An observational study of Lung Non-Small Cell Carcinoma, 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 30 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of decision aid (time frame: Up to study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2025.