Shared Decision Making in Patients With Lung Cancer

Recruiting

• Conditions: Lung Adenocarcinoma; Surgery
• Interventions: Other: Qualitative interviews

• 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: 2024-02
• Last Update Submitted: 2024-02-24
• Last Update Posted: 2024-02-28
• 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

Arm && Interventions

Group	Intervention	Description
Patients of Field testing /β tests	Qualitative interviews	Then the investigators will conduct the field testing (Beta test) with patient and clinician facing the decision in real time. The purpose of Beta test is to test the usability of DA_LCMT 2.0 in "real-world setting". Clinician and patients will use the DA_LCMT 2.0 for real-time decision making. The conversation of decision progress will be audio-recorded. After the decision is made by patients, structured interview will be conducted and audio-recorded separately between clinician and patients. All the field testing interviews will conducted one-on-one and written informed consent will be obtained prior to each interview. Each field testing interview will last for about 20 minutes.
Clinician of Field testing /β tests	Qualitative interviews	Then the investigators will conduct the field testing (Beta test) with patient and clinician facing the decision in real time. The purpose of Beta test is to test the usability of DA_LCMT 2.0 in "real-world setting". Clinician and patients will use the DA_LCMT 2.0 for real-time decision making. The conversation of decision progress will be audio-recorded. After the decision is made by patients, structured interview will be conducted and audio-recorded separately between clinician and patients. All the field testing interviews will conducted one-on-one and written informed consent will be obtained prior to each interview. Each field testing interview will last for about 20 minutes.
Other stakeholders of decision making need assessment	Qualitative interviews	We will conduct semi-structured interviews with other stakeholders to assess their decisional needs. All interviews will be conducted one-to-one and be audio-recorded for further analysis. Written informed consent will be obtained prior to each interview. Nonrandom purposive sampling will be used to select key respondents to conduct in depth interview. Snowball sampling, where potential participants are asked to identify others who may be willing to participate, as well as convenience sampling, will be utilized. For other stakeholders (including thoracic surgeons, nurses, psychoanalyst, hospital administrators, molecular testing company staffs and insurance company staffs), region, seniority, position, and attitude toward both molecular testing and SDM are considered. All participants should be Chinese-speaking.
Patients of decision making need assessment	Qualitative interviews	We will conduct semi-structured interviews with target patients and patients' representatives to assess their decisional needs. Decisional needs including difficult decision type /timing, unreceptive decisional stage, decisional conflict (uncertainty), inadequate knowledge \& unrealistic expectations, unclear values, inadequate support \& resources, and Personal \& clinical needs. All interviews will be conducted one-to-one or one-to-many (including families) and be audio-recorded for further analysis. Written informed consent will be obtained prior to each interview. Nonrandom purposive sampling will be used to select key respondents to conduct in depth interview. Snowball sampling, where potential participants are asked to identify others who may be willing to participate, as well as convenience sampling, will be utilized. For patients, aiming for diversity regarding age, sex, education level and annual household income. All participants should be Chinese-speaking.
Participants of cognitive debriefing/alpha tests	Qualitative interviews	The purpose of Alpha test is to test the understandability of Decision Aid for Lung Cancer Molecular Testing version 1.0 (DA_LCMT 1.0). All debriefing interviews will be conducted one-on-one with structured probing questions. Participants will be encouraged to comment on DA_LCMT 1.0 and give recommendations to replace any unclear wording. At the start, the interviewer will explain the aim of the study and the procedures of the cognitive debriefing to participants. Then a paper-based DA_LCMT 1.0 will be given to participants, and sufficient time will be guaranteed to allow them to read DA_LCMT 1.0. The cognitive debriefing interview will start afterwards, and participants will answer questions probing questions asked by interviewers about DA_LCMT 1.0. Each cognitive debriefing interview will last for about 20 minutes. DA_LCMT 2.0 will be generated after the completion of the cognitive debriefing (Alpha test).

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