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Trial record 1 of 1 for:    STOP-OP
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Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients (STOP-OP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188446
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Frederiksberg University Hospital
Aalborg University Hospital
Copenhagen University Hospital at Herlev
Odense University Hospital
Aarhus University Hospital
Karolinska Institutet
Information provided by (Responsible Party):
Susanne Vahr lauridsen, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Smoking Alcohol Consumption Behavioral: Educational programme for smoking and alcohol cessation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188446


Locations
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Denmark
Department of Urology, University Hospital of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Frederiksberg University Hospital
Aalborg University Hospital
Copenhagen University Hospital at Herlev
Odense University Hospital
Aarhus University Hospital
Karolinska Institutet
Investigators
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Study Chair: Hanne Tønnesen, Professor WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susanne Vahr lauridsen, MEd, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02188446    
Other Study ID Numbers: F-22841-01
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Keywords provided by Susanne Vahr lauridsen, Rigshospitalet, Denmark:
Radical cystectomy
Bladder cancer
Smoking cessation
Alcohol cessation
Postoperative complications
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Postoperative Complications
Alcohol Drinking
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
Pathologic Processes
Drinking Behavior