Clinical trial NCT02188446: Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Smoking
Alcohol Consumption
Keywords: Radical cystectomy
Bladder cancer
Smoking cessation
Alcohol cessation
Postoperative complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Frederiksberg University Hospital
name: Aalborg University Hospital
name: Copenhagen University Hospital at Herlev
name: Odense University Hospital
name: Aarhus University Hospital
name: Karolinska Institutet
First posted: 2014-07-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with postoperative complications
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Postoperative complications
timeFrame: up to 90 days
measure: Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
timeFrame: Up to 12 months postoperatively
measure: Length of stay
timeFrame: From day of surgery to day of discharge
measure: Time to return to work or habitual level of activity
timeFrame: Up to 12 months
measure: Mortality
timeFrame: Up to 12 months postoperatively
measure: Quality of life ( EORTC QLQ BLM 30 and EQ5D)
timeFrame: Up to 12 months postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Urology, University Hospital of Copenhagen
Study officials:
affiliation: WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
name: Hanne Tønnesen, Professor
role: STUDY_CHAIR
References:
citation: Merzaai B, Tonnesen H, Rasmussen M, Lauridsen SV. Perioperative Alcohol and Smoking Cessation Intervention: Impact on Other Lifestyles. Semin Oncol Nurs. 2021 Feb;37(1):151116. doi: 10.1016/j.soncn.2020.151116. Epub 2021 Jan 6.
citation: Lauridsen SV, Thomsen T, Thind P, Tonnesen H. STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. Trials. 2017 Jul 17;18(1):329. doi: 10.1186/s13063-017-2065-6.