C67
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Histologically confirmed urothelial carcinoma stages T1–T3, N0–N1, M0 - Active nicotine consumption, defined as =5 cigarettes per day - Planned or performed surgical treatment, e.g., transurethral resection of a bladder tumor (TUR-B) or radical cystectomy - Age =18 years - Written informed consent to participate in the study after being informed according to ethical guidelines
Exclusion criteria
Exclusion criteria: - Exclusion from participation or lack of capacity to consent - Presence of a severe physical or mental illness that significantly limits participation in smoking cessation or the conduct of the study - Non-smokers or former smokers who have been abstinent from nicotine for more than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of tumor recurrence in patients with successful nicotine cessation compared to patients without nicotine cessation, measured at three time points (6 weeks, 6 months, and 12 months after completion of the cessation program). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in quality of life measured with a validated QoL instrument (e.g., EORTC QLQ-C30) at the specified time points. • Change in disease-related coping strategies (e.g., assessed using the "FKV – Questionnaire for Coping with Illness"). • Success rate of nicotine abstinence in the two intervention groups over a period of 12 months. | — |
Countries
Germany
Contacts
Urologische Klinik am Hegau-Bodensee Klinikum Singen