Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients
Conditions
Bladder Cancer - Smokers - Alcohol Consumption
Conditions: official terms
Alcohol Drinking - Postoperative Complications - Urinary Bladder Neoplasms
Conditions: Keywords
Radical cystectomy, Bladder cancer, Smoking cessation, Alcohol cessation, Postoperative complications
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Educational programme for smoking and alcohol cessation
Type: Behavioral
Overall Status
Recruiting
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 160 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of Urology, University Hospital of Copenhagen
Copenhagen, Denmark
Status: Recruiting
Contact: Susanne V Lauridsen, PhD student - +4535451704
Start Date
November 2014
Completion Date
March 2017
Sponsors
Rigshospitalet, Denmark
Source
Rigshospitalet, Denmark
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page