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Completed

NCT Number: NCT02188446

Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

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.

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Key information

Conditions

Bladder Cancer Alcohol Consumption Alcohol Drinking Behavior Drinking Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Smoking Smoking Cessation Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University Hospital of Copenhagen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational programme for smoking and alcohol cessation

Behavioral

5 meetings within 6 weeks containing education and pharmacologic support

Other names: GSP

Primary outcomes

  1. Number of patients with postoperative complications

    Time frame: Up to 6 weeks

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

Secondary outcomes

  1. Postoperative complications

    Time frame: up to 90 days

  2. Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation

    Time frame: Up to 12 months postoperatively

  3. Length of stay

    Time frame: From day of surgery to day of discharge

  4. Time to return to work or habitual level of activity

    Time frame: Up to 12 months

  5. Mortality

    Time frame: Up to 12 months postoperatively

  6. Quality of life ( EORTC QLQ BLM 30 and EQ5D)

    Time frame: Up to 12 months postoperatively

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Copenhagen University Hospital at Herlev
  • Frederiksberg University Hospital
  • Karolinska Institutet
  • Odense University Hospital

Registry information

Official study 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

Acronym: STOP-OP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2014
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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