Background: Daily smoking and alcohol consumption exceeding 2 units per day increase the risk of postoperative complications, lifestyle-related morbidity and recurrence of cancer disease. Evidence indicates that smoking and alcohol cessation intervention lasting 4 weeks and more reduces the frequency of postoperative complications and increases long-term lifestyle change. Patients suffering from cancer are however scheduled for surgery within maximum 2 weeks of diagnosis. Preoperative intervention lasting 4 weeks or more is therefore not possible for these patients. Intervention initiated immediately before and continued at least 5 weeks postoperatively may hypothetically be equally effective.
Aim: To examine the effect of an intensive smoking and/or alcohol intervention initiated immediately before and continued 5 weeks after radical cystectomy versus standard preoperative care on postoperative complications, lifestyle change and quality of life up to 12 months postoperatively.
Methods: A single-blinded randomized controlled trial. Primary outcome: postoperative complications up to 90 days postoperatively assessed according to the Clavien-Dindo classification. Secondary outcomes: smoking and/or alcohol cessation, length of hospital stay, time to return to work, quality of life. Inclusion criteria: Patients scheduled for radical cystectomy, aged 18 years and above, who are daily smokers and/or drink more than 3 units of alcohol daily. The intervention includes behavioral counseling with trained cessation counselors and pharmacological support to stop smoking and/or drinking perioperatively. Patients are invited to attend 5 individual meetings over 6 weeks. The first meeting occurs shortly before surgery and the remaining meetings are scheduled postoperatively. Data analysis using non-parametric statistics and intention to treat analysis.
Results: The study is ongoing. We plan to present preliminary feasibility results (inclusion rate, patient compliance, lifestyle changes short-term) at the World Cancer Congress.
Conclusions: If effective for preventing postoperative complications and increasing smoking and alcohol cessation, the intervention may impact on quality of life in cancer survivors.