Shared Decision Making in Patients With Lung Cancer After Surgery：a Molecular Testing Decision Aid Evidence Based Development Study
概览
- 阶段
- 不适用
- 干预措施
- Qualitative interviews
- 疾病 / 适应症
- Surgery
- 发起方
- Sichuan Cancer Hospital and Research Institute
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- The DA_LCMT 3.0
- 状态
- 招募中
- 最后更新
- 前天
概览
简要总结
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.
详细描述
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.
研究者
Xing Wei, MD
Doctor
Sichuan Cancer Hospital and Research Institute
入排标准
入选标准
- •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.
排除标准
- •Inability to understand the research content.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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).
干预措施: 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.
干预措施: 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.
干预措施: Qualitative interviews
结局指标
主要结局
The DA_LCMT 3.0
时间窗: 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)