Shared Decision Making in Patients With Lung Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• The DA_LCMT 3.0 [Срок оценки: 3 days]

Критерии участия

Критерии включения

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.

Критерии исключения

Inability to understand the research content.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-кроссовер

Центры проведения

Китай · 1 центр

• Sichuan Cancer Hospital & Institute — Чэнду

Публикации

• 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

Идентификаторы

NCT: NCT05191485 · CN-SDM-Lung 1 Part I

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗