Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

Not Applicable

Completed

• Conditions: Bladder Cancer; Smoking; Alcohol Consumption
• Interventions: Behavioral: Educational programme for smoking and alcohol cessation

• Registration Number: NCT02188446
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Study Start: 2014-11
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smoking and alcohol cessation education	Educational programme for smoking and alcohol cessation	-

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative complications	Up to 6 weeks	Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	up to 90 days
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
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation	Up to 12 months postoperatively

Trial Locations

Locations (1)

Department of Urology, University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark