<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/NCT03839043</url>
  </required_header>
  <id_info>
    <org_study_id>18-010950</org_study_id>
    <nct_id>NCT03839043</nct_id>
  </id_info>
  <brief_title>Short Messaging Service Program to Help Quit Smoking During Perioperative Period.</brief_title>
  <acronym>SMS2QUIT</acronym>
  <official_title>Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking can increase the risk of complications around the time of surgery. Researchers are&#xD;
      trying to see if a text messaging program can help smokers stay off cigarettes around the&#xD;
      time of surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-term goal of the project is to increase the reach and effectiveness of tobacco use&#xD;
      interventions in healthcare settings. The main objective of this project is to determine&#xD;
      whether an innovative tobacco use intervention targeting abstinence from the morning of&#xD;
      surgery until one week after surgery (&quot;quit for a bit&quot;) can increase sustained engagement of&#xD;
      surgical patients in treatment compared with a standard tobacco use intervention that&#xD;
      specifically targets long-term abstinence (&quot;quit for good&quot;).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</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>Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a &quot;quit for a bit&quot; or a &quot;quit for good&quot; intervention. Both stratums employ a Short Message Service (SMS or &quot;text&quot;) to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The &quot;quit for a bit&quot; intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30</measure>
    <time_frame>30 days Post Op</time_frame>
    <description>Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of &quot;keywords&quot; sent via SMS by the subjects</measure>
    <time_frame>Cumulative from Day 1 to Day 30 Post Op</time_frame>
    <description>Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Tobacco Use Cessation</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <condition>Tobacco Smoking</condition>
  <arm_group>
    <arm_group_label>&quot;Quit for a bit&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + &quot;Quit for a bit&quot; SMS program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Quit for good&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +&quot; Quit for good&quot; SMS program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief behavioral intervention</intervention_name>
    <description>&quot;Quit for a bit&quot;- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. &quot;Quit for good&quot;- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.</description>
    <arm_group_label>&quot;Quit for a bit&quot;</arm_group_label>
    <arm_group_label>&quot;Quit for good&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Program</intervention_name>
    <description>&quot;Quit for a bit&quot;- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days.&quot;Quit for good&quot;- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.</description>
    <arm_group_label>&quot;Quit for a bit&quot;</arm_group_label>
    <arm_group_label>&quot;Quit for good&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes&#xD;
             every day or most days within the week prior to enrollment&#xD;
&#xD;
          -  Willingness to either &quot;quit for a bit&quot; or &quot;quit for good&quot; in the perioperative period,&#xD;
             and;&#xD;
&#xD;
          -  Owning a device with access to SMS with an unlimited text plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgery on the day of POE evaluation&#xD;
&#xD;
          -  Any active psychiatric condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David O Warner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>David Warner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Tobacco</keyword>
  <keyword>Cigarettes</keyword>
  <keyword>Surgery</keyword>
  <keyword>Text Message</keyword>
  <keyword>SMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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/NCT03839043
org study id: 18-010950
nct id: NCT03839043
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Smoking can increase the risk of complications around the time of surgery. Researchers are
      trying to see if a text messaging program can help smokers stay off cigarettes around the
      time of surgery.
The long-term goal of the project is to increase the reach and effectiveness of tobacco use
      interventions in healthcare settings. The main objective of this project is to determine
      whether an innovative tobacco use intervention targeting abstinence from the morning of
      surgery until one week after surgery ("quit for a bit") can increase sustained engagement of
      surgical patients in treatment compared with a standard tobacco use intervention that
      specifically targets long-term abstinence ("quit for good").
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a "quit for a bit" or a "quit for good" intervention. Both stratums employ a Short Message Service (SMS or "text") to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The "quit for a bit" intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.
measure: Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
time frame: 30 days Post Op
description: Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.
measure: The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects
time frame: Cumulative from Day 1 to Day 30 Post Op
description: Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service
arm group label: "Quit for a bit"
arm group type: Experimental
description: Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program.
arm group label: "Quit for good"
arm group type: Active Comparator
description: Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program.
intervention type: Behavioral
intervention name: Brief behavioral intervention
description: "Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.
arm group label: "Quit for a bit"
arm group label: "Quit for good"
intervention type: Other
intervention name: SMS Program
description: "Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.
arm group label: "Quit for a bit"
arm group label: "Quit for good"
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David O Warner, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: David Warner
investigator title: Principal Investigator
mesh term: Postoperative Complications