Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients (STOP-OP)

Rigshospitalet

Status: Completed

Conditions: Alcohol Consumption; Bladder Cancer; Smoking

Treatments: Behavioral: Educational programme for smoking and alcohol cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT02188446

F-22841-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Smoking and alcohol cessation education

Experimental group

Treatment:

Behavioral: Educational programme for smoking and alcohol cessation

Standard treatment

No Intervention group

Description:

Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.