NCT05191485

Shared Decision Making in Patients With Lung Cancer

Shared Decision Making in Patients With Lung Cancer After Surgery：a Molecular Testing Decision Aid Evidence Based Development Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 190 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to develop a Decision Aid for Lung Cancer Molecular Testing (DA\_LCMT) and to facilitate shared-decision making in patients who were diagnosed with lung adenocarcinoma by intraoperative frozen pathology about whether to conduct the molecular testing.

Detailed description

Under the guidance by Ottawa Decision Support Framework (ODSF), International Patient Decision Aid Standards (IPDAS) and FDA guidance for Identify what is important to patients, the investigators use semi-structured interviews qualitative research methods to generate the decision making needs items of lung cancer patients who were diagnosed with lung adenocarcinoma by intraoperative frozen section pathology and other stakeholders (including thoracic surgeons, nurses, hospital administrators, molecular testing company staffs and insurance company staffs). Then modified Delphi will be used to develop the Decision Aid for Lung Cancer Molecular Testing version 1.0 (DA\_LCMT 1.0). One-to-one structured interviews qualitative research methods will be used in the Cognitive debriefing (alpha tests) and Field testing (β tests) to revise and improve the DA\_LCMT from version 1.0 to finally version 3.0. Descriptive statistics will be used to summarize the baseline characteristics of patients and other stakeholders. Qualitative data will be analyzed by the three steps proposed by grounded theory.

Conditions

• Surgery
• Lung Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Qualitative interviews	We will conduct semi-structured interviews with target patients, patients' representatives and other stakeholders to assess their decisional needs. The cognitive debriefing interview will start afterwards, and participants will answer probing questions asked by interviewers about DA\_LCMT 1.0. Then the field testing interviews will conducted one-on-one structured interviews.

Timeline

• Start date: 2023-02-22
• Primary completion: 2025-12-31
• Completion: 2026-12-01
• First posted: 2022-01-13
• Last updated: 2025-06-04

Locations

1 site across 1 country: China