Clinical trial · Observational
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
NCT05191485CI-TRIAL-00109895recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Qualitative interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Patients of decision making need assessment
- description
- 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.
- interventionNames
- Other: Qualitative interviews
- label
- Other stakeholders of decision making need assessment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWei 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