Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

NCT02188446 | Completed

• 1 other identifier: F-22841-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Smoking; Alcohol Consumption

Keywords

Radical cystectomy; Bladder cancer; Smoking cessation; Alcohol cessation; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Number of patients with postoperative complications

  Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured

  Up to 6 weeks

Secondary Outcomes (6)

• Postoperative complications

  up to 90 days

• Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation

  Up to 12 months postoperatively

• 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

Study Arms (2)

Smoking and alcohol cessation education

EXPERIMENTAL

Behavioral: Educational programme for smoking and alcohol cessation

Standard treatment

NO INTERVENTION

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

Interventions

Educational programme for smoking and alcohol cessation BEHAVIORAL

5 meetings within 6 weeks containing education and pharmacologic support

Also known as: GSP

Smoking and alcohol cessation education

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cancelled operation
• Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
• Pregnant or breastfeeding women
• Mentally incompetent patients

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Frederiksberg University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Department of Urology, University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 33422365 DERIVED

• 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.

  PMID: 28716147 DERIVED

Related Links

• DaBlaCa study number 6

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Smoking; Alcohol Drinking; Smoking Cessation; Postoperative Complications

Interventions

Smoking Devices; Ethanol

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Behavior; Drinking Behavior; Health Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Organic Chemicals

Study Officials

• Hanne Tønnesen, Professor

  WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEd, PhD student

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: July 11, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

DK (1)