Shared Decision Making in Patients With Lung Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191485
• Other study ID #: CN-SDM-Lung 1 Part I
• Status: Recruiting
• Start date: February 22, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patients of decision-making need assessment:

1) age = 18 years; 2) patients with primary invasive adenocarcinoma of lung diagnosed by intraoperative frozen pathological section; 3) have or have not made a decision on lung cancer molecular testing (whether to perform molecular testing or not).

Other stakeholders of decision-making need assessment:

1) age = 18 years; 2) relevant work experience = 2 years; 3) for thoracic surgeons and personnel in molecular testing companies: have previous experience in communicating with patients about molecular testing related to lung cancer targeted therapy; 4) for nurses, hospital administrators, and personnel in insurance companies: have a certain understanding of the decision-making process.

Patients of Cognitive debriefing/Alpha tests:

1) age = 18 years; 2) patients with primary invasive adenocarcinoma of lung diagnosed by intraoperative frozen pathological section; 3) have made a decision on whether to perform lung cancer molecular testing or not.

other stakeholders of Cognitive debriefing/Alpha tests:

1) age = 18 years; 2) relevant work experience = 2 years; 3) for thoracic surgeons and personnel in molecular testing companies: have previous experience in communicating with patients about molecular testing related to lung cancer targeted therapy; 4) for nurses, hospital administrators, and personnel in insurance companies: have a certain understanding of the decision-making process.

Patients of field testing /Beta tests:

1) age = 18 years; 2) patients with primary invasive adenocarcinoma of lung diagnosed by intraoperative frozen pathological section; 3) have not decided whether to perform lung cancer molecular testing or not.

Clinician of field testing /Beta tests:

1) age = 18 years; 2) relevant work experience = 2 years; 3) previous experience in communicating with patients about molecular testing related to lung cancer targeted therapy; and 4) voluntarily participated in this study.

Exclusion criteria:

Inability to understand the research content.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital & Institute	Chengdu	Sichuan

Sponsors (5)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute	Chongqing Medical University, Jiangyou People's Hospital, The Third People's Hospital of Chengdu, Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The DA_LCMT 3.0	The DA_LCMT 3.0 is the final version in this study which must conform to the International Patient Decision Aid Standards (IPDAS)	3 days