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This is a cross-sectional, non-interventional qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 participants will be enrolled, comprising around 85 patients and 15 physicians. All participants will be interviewed online or in-person using a COM-B (Capability, Opportunity, Motivation - Behaviour) based guide. Interviews will be conducted in waves, recorded, transcribed, and analysed using both deductive and inductive methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interview-Physicians | Interview the physicians experienced in prescribing osimertinib and managing osimertinib-treated patients | ||
| Interview-Patients | Interview the Patients with treated with osimertinib for less 6 months, 6-18 months, 18-34 months, more than 34 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Barriers to persistence | to identify factors that prevent patients from maintaining persistence to osimertinib adjuvant treatment. Barriers may include adverse effects, logistical challenges, financial constraints, psychosocial issues, communication gaps, etc. | Day of interview completion |
| Facilitators of persistence | to determine factors that support patients in continuing osimertinib adjuvant treatment. Facilitators may include perceived efficacy, effective management of side effects, strong physician-patient communication, practical supports, family or peer encouragement, etc. | Day of interview completion |
| Measure | Description | Time Frame |
|---|---|---|
| Barriers and facilitators of persistence in different treatment duration cohorts | Barriers and facilitators of persistence in different treatment duration cohorts. | Day of interview completion |
| Support needed by patients during their long-term treatment journey |
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For patient
Inclusion Criteria:
Exclusion Criteria:
For physicians
Inclusion Criteria:
Exclusion Criteria:
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Include adult patients with early-stage NSCLC who received adjuvant osimertinib after curative surgery, as well as physicians experienced in prescribing adjuvant osimertinib.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | China |
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.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Support needed by patients during their long-term treatment journey: to highlight what additional information, tools, or services patients feel would help sustain persistence |
| Day of interview completion |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |