Shared Decision Making in Patients With Lung Cancer

Recruiting

• Conditions: Lung Adenocarcinoma; Surgery

• Registration Number: NCT05191485
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-01
• Study First Submitted QC: 2022-01-02
• Study First Posted: 2022-01-13
• Study Start: 2023-02-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The DA_LCMT 3.0	3 days	The DA_LCMT 3.0 is the final version in this study which must conform to the International Patient Decision Aid Standards (IPDAS)

Trial Locations

Locations (1)

Sichuan Cancer Hospital & Institute; 🇨🇳 Chengdu, Sichuan, China