Barriers and Facilitators of Persistence With Adjuvant Osimertinib
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 →
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Official title
Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)
Overview
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.
Primary outcome measures
- Barriers to persistence [Time frame: Day of interview completion]
- Facilitators of persistence [Time frame: Day of interview completion]
Secondary outcome measures (2)
- Barriers and facilitators of persistence in different treatment duration cohorts [Time frame: Day of interview completion]
- Support needed by patients during their long-term treatment journey [Time frame: Day of interview completion]
Eligibility criteria
For patient
Inclusion criteria
- Adults (≥18 years) with NSCLC who have received osimertinib as the 3rd generation EGFR-TKI adjuvant therapy and meet one of the following: Patients who received adjuvant osimertinib for less than 34 months and discontinued treatment (off treatment), or Patients who received adjuvant osimertinib for at least 34 months (either off treatment or still on treatment).
- For off treatment patients, discontinuation or completion of osimertinib is required to occur within 6 months by screening.
- Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.
Exclusion criteria
- Prior receipt of 3rd generation EGFR-TKI as adjuvant therapy as part of any interventional clinical trial.
- Prior receipt of 1st generation EGFR-TKIs as adjuvant therapy.
- Evidence of cognitive impairment that would likely to interfere with participation in an interview, as informally assessed during screening.
- Unaware of or do not understand their own medical condition.
For physicians
Inclusion criteria
- Licensed medical oncologists, thoracic surgeons, or pulmonologists with experience of prescribing osimertinib as adjuvant treatment and actively managing patients who will participate the interview.
- Managed 5 patients with early-stage NSCLC receiving osimertinib within the past 6 months.
- Holding a professional title equivalent to or higher than attending physician.
- Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.
Exclusion criteria
- Unable or unwilling to follow study procedures.
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
- Cohort
Study locations
China · 1 center
- Research Site — Beijing
Identifiers
NCT: NCT07542210 · D516AR00002