<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188446</url>
  </required_header>
  <id_info>
    <org_study_id>F-22841-01</org_study_id>
    <nct_id>NCT02188446</nct_id>
  </id_info>
  <brief_title>Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients</brief_title>
  <acronym>STOP-OP</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Frederiksberg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial&#xD;
      cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol&#xD;
      consumption above two drinks per day is associated with an increased risk of postoperative&#xD;
      morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is&#xD;
      recommended to reduce this risk, but for cancer patients the preoperative period is often&#xD;
      very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of&#xD;
      a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the&#xD;
      Gold Standard Programme (GSP) on the frequency and severity of postoperative complications&#xD;
      after bladder cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a multicentre randomised clinical trial involving 110 patients with a risky&#xD;
      alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking&#xD;
      scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or&#xD;
      treatment as usual (control). The GSP combines patient education and pharmacologic&#xD;
      strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled&#xD;
      disulfiram therapy, and Nicotine replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with postoperative complications</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation</measure>
    <time_frame>Up to 12 months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>From day of surgery to day of discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to work or habitual level of activity</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 12 months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life ( EORTC QLQ BLM 30 and EQ5D)</measure>
    <time_frame>Up to 12 months postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Smoking</condition>
  <condition>Alcohol Consumption</condition>
  <arm_group>
    <arm_group_label>Smoking and alcohol cessation education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational programme for smoking and alcohol cessation</intervention_name>
    <description>5 meetings within 6 weeks containing education and pharmacologic support</description>
    <arm_group_label>Smoking and alcohol cessation education</arm_group_label>
    <other_name>GSP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years scheduled for cystectomy due to bladder cancer&#xD;
&#xD;
          -  Daily smoker or/and intake of&#xD;
&#xD;
             -&gt;21 units (252 g) of alcohol pr week&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancelled operation&#xD;
&#xD;
          -  Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Mentally incompetent patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanne Tønnesen, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology, University Hospital of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://ducg.dk/dablaca-blaerecancer/forskningsprojekter/</url>
    <description>DaBlaCa study number 6</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>May 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Susanne Vahr lauridsen</investigator_full_name>
    <investigator_title>MEd, PhD student</investigator_title>
  </responsible_party>
  <keyword>Radical cystectomy</keyword>
  <keyword>Bladder cancer</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>Alcohol cessation</keyword>
  <keyword>Postoperative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188446
org study id: F-22841-01
nct id: NCT02188446
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of patients with postoperative complications
time frame: Up to 6 weeks
description: Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured
measure: Postoperative complications
time frame: up to 90 days
measure: Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
time frame: Up to 12 months postoperatively
measure: Length of stay
time frame: From day of surgery to day of discharge
measure: Time to return to work or habitual level of activity
time frame: Up to 12 months
measure: Mortality
time frame: Up to 12 months postoperatively
measure: Quality of life ( EORTC QLQ BLM 30 and EQ5D)
time frame: Up to 12 months postoperatively
arm group label: Smoking and alcohol cessation education
arm group type: Experimental
arm group label: Standard treatment
arm group type: No Intervention
description: Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.
intervention type: Behavioral
intervention name: Educational programme for smoking and alcohol cessation
description: 5 meetings within 6 weeks containing education and pharmacologic support
arm group label: Smoking and alcohol cessation education
other name: GSP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Hanne Tønnesen, Professor
role: Study Chair
affiliation: WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
facility: 
country: Denmark
url: http://ducg.dk/dablaca-blaerecancer/forskningsprojekter/
description: DaBlaCa study number 6
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Susanne Vahr lauridsen
investigator title: MEd, PhD student
mesh term: Urinary Bladder Neoplasms
mesh term: Postoperative Complications
mesh term: Alcohol Drinking