Developing a Shared Decision Making Tool for Patients With Surgically Removed Non-small Cell Lung Cancer

Lung Non-Small Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416983
• Other study ID #: 21-013359
• Secondary ID: NCI-2022-01685
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Non-Small Cell Carcinoma

Intervention

Procedure:
• Discussion
Attend discussion

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of decision aid		Up to study completion, up to 2 years