Shared Decision Making in Patients With Lung Cancer

NCT05191485 | Recruiting DMC

• 1 other identifier: CN-SDM-Lung 1 Part I
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Lung Adenocarcinoma

Keywords

Shared-decision making; Decision aid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Patients of decision making need assessment

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.

Other: Qualitative interviews

Other stakeholders of decision making need assessment

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.

Other: Qualitative interviews

Participants of cognitive debriefing/alpha tests

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).

Other: Qualitative interviews

Patients of Field testing /β tests

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: Qualitative interviews

Clinician of Field testing /β tests

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: Qualitative interviews

Interventions

Qualitative interviews OTHER

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.

Clinician of Field testing /β tests; Other stakeholders of decision making need assessment; Participants of cognitive debriefing/alpha tests; Patients of Field testing /β tests; Patients of decision making need assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-random purposive sampling will be used to select key respondents to participate in in-depth interviews. 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, we will aim for diversity regarding age, sex, education level, and annual household income. For other stakeholders (including thoracic surgeons, nurses, psychoanalysts, hospital administrators, molecular testing company staff, and insurance company staff), the representativeness in region, seniority, position, and attitude toward both molecular testing and SDM will be considered.

You may qualify if:

• Patients of decision-making need assessment:
• \) 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:
• \) 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:
• \) 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:
• \) 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:
• \) 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:
• \) 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.

You may not qualify if:

• Inability to understand the research content.

Sponsors & Collaborators

• Jiangyou People's Hospital: collaborator
• Wu Jieping Medical Foundation: collaborator
• Chongqing Medical University: collaborator
• The Third People's Hospital of Chengdu: collaborator
• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

• Wei X, Liu Y, Yu H, Dai W, Yang D, Zhang K, Sun J, Xu W, Gong R, Yu Q, Pu Y, Wang Y, Liao J, Mu Y, Zhang Y, Feng W, Pan Q, Li Q, Shi Q. Protocol of an iterative qualitative study to develop a molecular testing decision aid for shared decision-making in patients with lung cancer after surgery. BMJ Open. 2022 Sep 19;12(9):e061367. doi: 10.1136/bmjopen-2022-061367.

  PMID: 36123064 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: January 13, 2022
• Study Start: February 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)