Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

Study Overview
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Brief Summary
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Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.

Detailed Description
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The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.

Official Title
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Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications

Conditions
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Bladder Cancer, Smoking, Alcohol Consumption

Intervention / Treatment
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* Behavioral: Educational programme for smoking and alcohol cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years scheduled for cystectomy due to bladder cancer Daily smoker or/and intake of ->21 units (252 g) of alcohol pr week Informed consent Exclusion Criteria: Cancelled operation Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement Pregnant or breastfeeding women Mentally incompetent patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking and alcohol cessation education<br> | Behavioral: Educational programme for smoking and alcohol cessation<br>* 5 meetings within 6 weeks containing education and pharmacologic support<br>* Other names: GSP;|
| No Intervention: Standard treatment<br>Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative complications | Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | up to 90 days | 
| Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation |  | Up to 12 months postoperatively | 
| Length of stay |  | From day of surgery to day of discharge | 
| Time to return to work or habitual level of activity |  | Up to 12 months | 
| Mortality |  | Up to 12 months postoperatively | 
| Quality of life ( EORTC QLQ BLM 30 and EQ5D) |  | Up to 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical cystectomy, Bladder cancer, Smoking cessation, Alcohol cessation, Postoperative complications