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

January 31, 2019 updated by: Susanne Vahr lauridsen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Urology, University Hospital of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking and alcohol cessation education
Behavioral: Educational programme for smoking and alcohol cessation
5 meetings within 6 weeks containing education and pharmacologic support
Other Names:
  • GSP
No Intervention: Standard treatment
Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications
Time Frame: up to 90 days
up to 90 days
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
Time Frame: Up to 12 months postoperatively
Up to 12 months postoperatively
Length of stay
Time Frame: From day of surgery to day of discharge
From day of surgery to day of discharge
Time to return to work or habitual level of activity
Time Frame: Up to 12 months
Up to 12 months
Mortality
Time Frame: Up to 12 months postoperatively
Up to 12 months postoperatively
Quality of life ( EORTC QLQ BLM 30 and EQ5D)
Time Frame: Up to 12 months postoperatively
Up to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

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

Investigators

  • Study Chair: Hanne Tønnesen, Professor, WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-22841-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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