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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Lung Adenocarcinoma
• Intervention / Treatment: Other: Qualitative interviews

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 Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital & Institute
      • Contact: Xing Wei; Phone Number: +86 17302886627; Email: 1015682256@qq.com
      • Contact: Wei Dai; Phone Number: +86 18608222758; Email: davii-i@126.com
      • Principal Investigator: Xing Wei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 1, 2022
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Decision aid; Shared-decision making
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma of Lung
• Other Study ID Numbers: CN-SDM-Lung 1 Part I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No