Helping lung cancer patients decide on molecular testing after surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lung adenocarcinoma found during surgery, and for doctors, nurses and other staff, to help build a decision aid about molecular testing.

Age

18 years or older

Sex

All sexes

Disease stage

Patients: primary invasive lung adenocarcinoma diagnosed by frozen section during surgery.

Earlier treatment

Patients must not yet have decided, or may have decided, on molecular testing, depending on the study part. Clinicians need past experience talking with patients about molecular testing for lung cancer targeted therapy.

Main reasons for not taking part

• Cannot understand the research content

The registry criteria, word for word

What the trial wants to find out

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.

The 5 groups in the trial

• 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.

  Treatment: 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.

  Treatment: 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).

  Treatment: 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.

  Treatment: 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.

  Treatment: Qualitative interviews