NCT02188446

Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Smoking
• Alcohol Consumption

Interventions

Type	Name	Description
BEHAVIORAL	Educational programme for smoking and alcohol cessation	5 meetings within 6 weeks containing education and pharmacologic support

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-07-11
• Last updated: 2019-02-04

Locations

1 site across 1 country: Denmark