- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413757
CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC (CHOICE)
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Chengdu, China, 610000
- Recruiting
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Physicians group
Physicians who have experience in the treatment and management of stage IV NSCLC patients with 1L EGFR-TKI.
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Patinet group
Patients receiving or who have received 1L EGFR-TKI treatment for stage IV NSCLC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preferences weights for each attribute level evaluated in the DCE
Time Frame: Day of interview/survey completion(Day1)
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Preference weights will be estimated for each attribute level included in the DCE where a more positive preference weight indicates a stronger preference for the attribute level.
The preference weights allow for comparison for relative preference for levels within the same attribute.
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Day of interview/survey completion(Day1)
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Relative attribute importance (RAI)
Time Frame: Day of interview/survey completion(Day1)
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The importance measure will be used to evaluate the preferences among treatment attributes.
This measure will be calculated by using the difference of utility scores between the most and least preferred levels within an attribute.
Then, this measure will divide by the summation of the difference of all tested attributes.
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Day of interview/survey completion(Day1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maximum acceptable risks (MAR) and minimum acceptable benefit (MAB)
Time Frame: Day of interview/survey completion(Day1)
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This measure will be used to evaluate the trade-offs participants are willing to make between an improvement in a pre-defined attribute related to efficiency (such as PFS) compared to a worsening in each AE relevant attribute (such as rash).
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Day of interview/survey completion(Day1)
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RAI, MAR, and MAB by patient and physician characteristics subgroups
Time Frame: Day of interview/survey completion(Day1)
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Day of interview/survey completion(Day1)
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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)
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o OR quantifies changes in the likelihood of physicians recommending combination therapy over monotherapy, depending on the presence or absence of specific patient characteristics (e.g., age, CNS metastases, high tumor burden).
An OR > 1 indicates an increased likelihood of recommending combination therapy for patients with the characteristic, while an OR < 1 indicates a decreased likelihood.
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Day of interview/survey completion(Day1)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5161R00072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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