- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05416983
Developing a Shared Decision Making Tool for Patients With Surgically Removed Non-small Cell Lung Cancer
The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients With Resected Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- PATIENTS
- Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Complete questionnaire
Attend discussion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Development of decision aid
Time Frame: Up to study completion, up to 2 years
|
Up to study completion, up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Konstantinos Leventakos, M.D., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-013359
- NCI-2022-01685 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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