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NCT Number: NCT05191485

Shared Decision Making in Patients With Lung Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of decision-making need assessment:

  • 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:

  • 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:

  • 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:

  • 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:

  • 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:

  • 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.

Treatment and study plan

Qualitative Interviews

Other

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.

Primary outcomes

  1. The DA_LCMT 3.0

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Collaborators

  • Chongqing Medical University
  • Jiangyou People's Hospital
  • The Third People's Hospital of Chengdu
  • Wu Jieping Medical Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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