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Trial Title:
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
NCT ID:
NCT06122064
Condition:
Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard of care
Arm group label:
Arm I (standard of care)
Arm group label:
Arm II (standard of care, conversation aid)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Use shared decision-making conversation tool
Arm group label:
Arm II (standard of care, conversation aid)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I (standard of care)
Arm group label:
Arm II (standard of care, conversation aid)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (standard of care)
Arm group label:
Arm II (standard of care, conversation aid)
Intervention type:
Other
Intervention name:
Video Recording
Description:
Ancillary studies
Arm group label:
Arm I (standard of care)
Arm group label:
Arm II (standard of care, conversation aid)
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Konstantinos Leventakos, M.D., Ph.D.
Email:
Principal Investigator
Start date:
November 20, 2023
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06122064
https://www.mayo.edu/research/clinical-trials
