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

Recruiting

• Conditions: Lung Non-Small Cell Carcinoma
• Interventions: Procedure: Discussion; Other: Questionnaire Administration

• Registration Number: NCT05416983
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study Start: 2022-02-17
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Read More

Exclusion Criteria

• PATIENTS
• Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (discussion)	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.
Observational (discussion)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Development of decision aid	Up to study completion, up to 2 years

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States