Clinical trial · Observational
Barriers and Facilitators of Persistence With Adjuvant Osimertinib
Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Interview-Physicians
- description
- Interview the physicians experienced in prescribing osimertinib and managing osimertinib-treated patients
- label
- Interview-Patients
- description
- Interview the Patients with treated with osimertinib for less 6 months, 6-18 months, 18-34 months, more than 34 months
Primary outcomes (2)
- measure
- Barriers to persistence
- timeFrame
- Day of interview completion
- description
- 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.
- measure
- Facilitators of persistence
- timeFrame
- Day of interview completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available