xml: <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/NCT05961813</url>
    </required_header>
    <id_info>
      <org_study_id>PR-483/2021</org_study_id>
      <nct_id>NCT05961813</nct_id>
    </id_info>
    <brief_title>Intervention for Smoking Cessation in Pre-Surgical Patients.</brief_title>
    <official_title>Evaluación de la Eficacia de Una intervención Para Dejar de Fumar en Pacientes prequirúrgicos de cirugía ortopédica o de cirugía General y urológica: Ensayo clínico Aleatorizado.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Universitari Vall d'Hebron Research Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess efficacy of an intensive pre-surgical&#xD;
        intervention to quit smoking in smoking patients who will be operated on implant orthopedic&#xD;
        surgery or general and urological surgery. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to&#xD;
             a brief intervention&#xD;
  &#xD;
          -  Evaluate the implementation of this protocol.&#xD;
  &#xD;
        Participants will be randomized to 2 intervention groups (patients programmed for protesic&#xD;
        implant orthopedic surgery in the first group, and general and urological surgery) and 2&#xD;
        control groups (stratified in the same manner as the intervention groups), and will be&#xD;
        monitored through telematic check ups via phone calls.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Subject recruitment in pre surgical anesthesiology consults, data collection and&#xD;
             randomization within 48 hours of said visit.&#xD;
  &#xD;
          2. Subjects in the intensive intervention group will be sent to a specialized Preventive&#xD;
             Medicine consult for smoking cessation, completing 6 visits (2 before surgical&#xD;
             intervention, 4 visits withint the following 12 months). Subjects in the control group&#xD;
             will receive brief advice on quitting smoking through a phone call the the same day&#xD;
             randomization is performed. Both groups will receive follow up calls at months 1, 3, 6,&#xD;
             and 12, after surgical intervetion. All patients will have their smoking habits&#xD;
             evaluated and the relevant data about the surgical intervention collected the day of the&#xD;
             intervention.&#xD;
  &#xD;
          3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are&#xD;
             necessary.&#xD;
  &#xD;
          4. Data entry and quality control of the database will be performed periodically for the&#xD;
             duration of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 20, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized, open, controlled clinical trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tobacco use</measure>
      <time_frame>Evaluated at 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Change in self reported tobacco use (smoking)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in concentration of exhaled CO measured with a CO-oximeter</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>A patient will be considered as an active tobacco user if more than 6 of carboxyhemoglobin particles per million are found through the use of a CO-oximeter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in rate of different type of tobbaco product users</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Cigarettes, cigars, rolling tobacco, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in tobacco use pattern</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Amount and frequency (daily, weekly, sporadically)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in degree of nicotine dependency</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Fagerström test [low dependency (0-3), medium dependency (4-6), y high dependency (7-10)]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in disposition to smoking cessation</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Motivation level</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Richmond's test (&lt;3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in self-efficacy</measure>
      <time_frame>Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention</time_frame>
      <description>Albert Bandura's social cognitive theory</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with surgical complicatoins</measure>
      <time_frame>Hospitalization period and 90 days after surgical intervention.</time_frame>
      <description>Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgery duration</measure>
      <time_frame>Day of intervention</time_frame>
      <description>Time spent in the operation room</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need of blood transfusion</measure>
      <time_frame>Day of intervention</time_frame>
      <description>Volume of blood transfused during surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization duration</measure>
      <time_frame>Days from admitting until discharge.</time_frame>
      <description>Number of days of hospitalization after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need of new hospitalizations</measure>
      <time_frame>12 months after surgical intervention.</time_frame>
      <description>Number of times patient is admitted to the hospital during follow up</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">232</enrollment>
    <condition>Smoking</condition>
    <condition>Smoking Cessation</condition>
    <condition>Surgical Procedure, Unspecified</condition>
    <arm_group>
      <arm_group_label>Intervention group in protesic implant orthopedic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will be sent to a specialized preventive medicine consult to quit smoking.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group in general and urological surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>58 patients programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will be sent to a specialized preventive medicine consult to quit smoking.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group in protesic implant orthopedic surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group in general and urological surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>58 programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will receive a brief intervention for smoking cessation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Intensive intervention for smoking cessation</intervention_name>
      <description>Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.</description>
      <arm_group_label>Intervention group in general and urological surgery</arm_group_label>
      <arm_group_label>Intervention group in protesic implant orthopedic surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brief intervention for smoking cessation</intervention_name>
      <description>Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.</description>
      <arm_group_label>Control group in general and urological surgery</arm_group_label>
      <arm_group_label>Control group in protesic implant orthopedic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must 18 years old or older, and be able to consent.&#xD;
  &#xD;
            -  Surgery programmed for at least 4 weeks after inclusion in the study.&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Already under treatment for smoking cessation&#xD;
  &#xD;
            -  Inability to consent due to cognitive impairment or language barrier.&#xD;
  &#xD;
            -  Non-primary knee or hip replacement surgery&#xD;
  &#xD;
            -  Participation in any study that forbids use of nicotine substitution therapy (dermal,&#xD;
               oral)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eva Gavilán Castillo, RN; MSN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vall d'Hebron Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eva Gavilán Castillo, RN; MSN</last_name>
      <phone>934893000</phone>
      <phone_ext>8021</phone_ext>
      <email>eva.gavilan@vallhebron.cat</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Universitari Vall d'Hebron</name>
        <address>
          <city>Barcelona</city>
          <state>Catalunya</state>
          <zip>08035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eva Gavilán Castillo, RN; MSN</last_name>
        <phone>934893000</phone>
        <phone_ext>8021</phone_ext>
        <email>eva.gavilan@vallhebron.cat</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Smoking</keyword>
    <keyword>Smoking Cessation</keyword>
    <keyword>Tobacco Use Disorder</keyword>
    <keyword>Surgery</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961813
  org study id: PR-483/2021
  nct id: NCT05961813
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess efficacy of an intensive pre-surgical
        intervention to quit smoking in smoking patients who will be operated on implant orthopedic
        surgery or general and urological surgery. The main question[s] it aims to answer are:
  
          -  Evaluate the efficacy of intensive pre surgical intervention to quit smoking compared to
             a brief intervention
  
          -  Evaluate the implementation of this protocol.
  
        Participants will be randomized to 2 intervention groups (patients programmed for protesic
        implant orthopedic surgery in the first group, and general and urological surgery) and 2
        control groups (stratified in the same manner as the intervention groups), and will be
        monitored through telematic check ups via phone calls.
  1. Subject recruitment in pre surgical anesthesiology consults, data collection and
             randomization within 48 hours of said visit.
  
          2. Subjects in the intensive intervention group will be sent to a specialized Preventive
             Medicine consult for smoking cessation, completing 6 visits (2 before surgical
             intervention, 4 visits withint the following 12 months). Subjects in the control group
             will receive brief advice on quitting smoking through a phone call the the same day
             randomization is performed. Both groups will receive follow up calls at months 1, 3, 6,
             and 12, after surgical intervetion. All patients will have their smoking habits
             evaluated and the relevant data about the surgical intervention collected the day of the
             intervention.
  
          3. At month 7 adecuacy of the protocol will be evaluated to assess if any modifications are
             necessary.
  
          4. Data entry and quality control of the database will be performed periodically for the
             duration of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, open, controlled clinical trial.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tobacco use
  time frame: Evaluated at 1, 3, 6, and 12 months after surgical intervention
  description: Change in self reported tobacco use (smoking)
  measure: Changes in concentration of exhaled CO measured with a CO-oximeter
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: A patient will be considered as an active tobacco user if more than 6 of carboxyhemoglobin particles per million are found through the use of a CO-oximeter
  measure: Changes in rate of different type of tobbaco product users
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Cigarettes, cigars, rolling tobacco, etc.
  measure: Changes in tobacco use pattern
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Amount and frequency (daily, weekly, sporadically)
  measure: Changes in degree of nicotine dependency
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Fagerström test [low dependency (0-3), medium dependency (4-6), y high dependency (7-10)]
  measure: Changes in disposition to smoking cessation
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Prochaska and Di Clemente's model (pre contemplation, contemplation, preparation, action, maintenance or relapse)
  measure: Changes in Motivation level
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Richmond's test (<3 no motivation; 4-5 doubtful motivation; 6-7 moderate motivation; 8-10 high motivation)
  measure: Changes in self-efficacy
  time frame: Evaluated at recruitment, and 1, 3, 6, and 12 months after surgical intervention
  description: Albert Bandura's social cognitive theory
  measure: Number of patients with surgical complicatoins
  time frame: Hospitalization period and 90 days after surgical intervention.
  description: Complications will be classified as respiratory, cardiovascular, surgical wound and complications, mortality
  measure: Surgery duration
  time frame: Day of intervention
  description: Time spent in the operation room
  measure: Need of blood transfusion
  time frame: Day of intervention
  description: Volume of blood transfused during surgery
  measure: Hospitalization duration
  time frame: Days from admitting until discharge.
  description: Number of days of hospitalization after surgery.
  measure: Need of new hospitalizations
  time frame: 12 months after surgical intervention.
  description: Number of times patient is admitted to the hospital during follow up
  arm group label: Intervention group in protesic implant orthopedic surgery
  arm group type: Experimental
  description: 58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will be sent to a specialized preventive medicine consult to quit smoking.
  arm group label: Intervention group in general and urological surgery
  arm group type: Experimental
  description: 58 patients programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will be sent to a specialized preventive medicine consult to quit smoking.
  arm group label: Control group in protesic implant orthopedic surgery
  arm group type: Active Comparator
  description: 58 patients programmed for knee or hip replacement surgeries, or spinal arthrodesis surgery who will receive a brief intervention for smoking cessation.
  arm group label: Control group in general and urological surgery
  arm group type: Active Comparator
  description: 58 programmed for colorrectal surgery due to colorrectal cancer, cistectomy, radical prostatectomy and partial or total nefrectomy, who will receive a brief intervention for smoking cessation.
  intervention type: Behavioral
  intervention name: Intensive intervention for smoking cessation
  description: Patients will be given a brochure and presentation on smoking cessation and will complete 6 visits (2 before surgical intervention, 4 visits within the following 12 months), as well as follow up phone calls for progressi monitorization.
  arm group label: Intervention group in general and urological surgery
  arm group label: Intervention group in protesic implant orthopedic surgery
  intervention type: Behavioral
  intervention name: Brief intervention for smoking cessation
  description: Patients will be given a brochure and presentation on smoking cessation 4 weeks before surgery, as well as follow up phone calls for progressi monitorization.
  arm group label: Control group in general and urological surgery
  arm group label: Control group in protesic implant orthopedic surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eva Gavilán Castillo, RN; MSN
  role: Principal Investigator
  affiliation: Vall d'Hebron Hospital
  last name: Eva Gavilán Castillo, RN; MSN
  phone: 934893000
  phone ext: 8021
  email: eva.gavilan@vallhebron.cat
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No