Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to persistence | Day of interview completion | 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. |
| Facilitators of persistence | Day of interview completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barriers and facilitators of persistence in different treatment duration cohorts | Day of interview completion | Barriers and facilitators of persistence in different treatment duration cohorts. |
| Support needed by patients during their long-term treatment journey | Day of interview completion | Support needed by patients during their long-term treatment journey: to highlight what additional information, tools, or services patients feel would help sustain persistence |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed