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Recruiting NCT07413757

CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC

— Observational Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)

Overview

This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.

Detailed description

This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.

The study will collect data from participants via the questionnaire developed by the research team. This study will be conducted in two stages. Stage 1 is the study design phase (i.e., qualitative stage and questionnaire development), which includes the development of the questionnaire, identification of key attributes and levels for the Discrete Choice Experiment (DCE), creation of hypothetical patient profiles to explore high-risk factors in physician decision-making beyond the DCE, as well as questionnaire programming, internal review, pilot testing, revisions, and finalization. Stage 2 involves the implementation of the quantitative survey using the finalized questionnaire and the subsequent data analysis to generate insights into treatment preferences.

Primary outcome measures

  • Preferences weights for each attribute level evaluated in the DCE [Time frame: Day of interview/survey completion(Day1)]
  • Relative attribute importance (RAI) [Time frame: Day of interview/survey completion(Day1)]
Secondary outcome measures (3)
  • Maximum acceptable risks (MAR) and minimum acceptable benefit (MAB) [Time frame: Day of interview/survey completion(Day1)]
  • RAI, MAR, and MAB by patient and physician characteristics subgroups [Time frame: Day of interview/survey completion(Day1)]
  • Odds ratios (ORs) for the association between patient characteristics and the likelihood of physicians recommending combination therapy (EGFR-TKI plus platinum/pemetrexed chemotherapy or EGFR-TKI plus bispecific antibody) versus EGFR-TKI monotherapy [Time frame: Day of interview/survey completion(Day1)]

Eligibility criteria

Inclusion criteria

The following inclusion criteria must be met in order to be enrolled in the stage 1:

Patient:

  • Provide informed consent
  • 18 years or older
  • Diagnosed with stage IV NSCLC
  • Currently receiving or previously received 1L EGFR-TKI treatment
  • Without communication barrier
  • Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter

Physician:

  • Provide informed consent
  • Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals
  • Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month
  • Holding the title of associate chief physician or higher

The following inclusion criteria must be met in order to be enrolled in the stage 2:

Patient:

  • Provide informed consent
  • 18 years or older
  • Diagnosed with stage IV NSCLC
  • Currently receiving or previously received 1L EGFR-TKI treatment
  • Without communication barrier
  • Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter

Physician:

  • Provide informed consent
  • Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals
  • Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month
  • Holding the title of attending physician or higher

Exclusion criteria

Not applicable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Research Site — Chengdu

Identifiers

NCT: NCT07413757 · D5161R00072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗