<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/NCT01685723</url>
  </required_header>
  <id_info>
    <org_study_id>cancer_rct_1</org_study_id>
    <nct_id>NCT01685723</nct_id>
  </id_info>
  <brief_title>Smoking Cessation in Cancer Patients</brief_title>
  <official_title>Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Food and Health Bureau, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Mary Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Elizabeth Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pamela Youde Nethersole Eastern Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Smoking cessation can largely improve cancer prognosis and quality of life among&#xD;
      cancer patients. However, few patients are aware of the importance to quit at the stage, or&#xD;
      they have difficulties to quit by self.&#xD;
&#xD;
      Aim: to examine the effectiveness of a smoking cessation intervention using a risk&#xD;
      communication approach&#xD;
&#xD;
      Design: A randomized controlled trial&#xD;
&#xD;
      Setting: Outpatient clinics of the Clinical Oncology Departments of five major hospitals in&#xD;
      different regions of Hong Kong&#xD;
&#xD;
      Subject: Smokers who attend medical follow-up visits at outpatient clinics of the Clinical&#xD;
      Oncology Departments of five major hospitals in different regions of Hong Kong and who met&#xD;
      the inclusion criteria were invited to participate.&#xD;
&#xD;
      Intervention: At baseline, intervention group receives:&#xD;
&#xD;
        1. a face-to-face individualized brief advice based on risk communication for 15-30 minutes&#xD;
           from the nurse counselors;&#xD;
&#xD;
        2. examination of exhale CO level; and&#xD;
&#xD;
        3. a generic standard self-help smoking cessation booklet. They will receive a booster&#xD;
           intervention at 1 week. Control group will receive standard care and a generic self-help&#xD;
           smoking cessation booklet.&#xD;
&#xD;
      Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month&#xD;
      follow up. Secondary outcomes include:&#xD;
&#xD;
        1. self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;&#xD;
&#xD;
        2. biochemically validated quit rate at 6-month follow-up; and&#xD;
&#xD;
        3. percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up&#xD;
           compared to baseline.&#xD;
&#xD;
      Significance: This study develops and validates practical smoking cessation interventions&#xD;
      targeted to cancer patients to improve their cancer prognosis and in long-term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking causes many types of cancer in general. Past studies have shown that current smokers&#xD;
      have increased risk of cancer, and most lung cancers are attributable to smoking. Cancer&#xD;
      (malignant neoplasm) is the number one killer in Hong Kong, which leads to nearly one-third&#xD;
      of all deaths each year. Cancer patients who continue smoking would result in extra risks of&#xD;
      all cause mortality, cancer recurrence and second primary cancer as well as reducing survival&#xD;
      time (Chen et al., 2010). Smoking could also reduce the efficacy of clinical and medical&#xD;
      treatment of cancer including radio- and chemo-therapies (Benninger et al., 1994; Browman et&#xD;
      al., 1993) and increase the risk of treatment related side-effects (Rugg et al., 1990).&#xD;
&#xD;
      Cancer patients may present an excellent &quot;teachable moment&quot; for smoking cessation&#xD;
      interventions, as their current illness could largely be due to smoking. However, few smoking&#xD;
      cessation programs target on this vulnerable group and only one-third of oncology nurses&#xD;
      would assist cancer patients quit smoking. Healthcare professionals have the responsibility&#xD;
      to assist this vulnerable group to quit smoking. Recent randomized controlled trials (RCT)&#xD;
      suggested behavioral intervention may help cancer patients quit smoking, but they are limited&#xD;
      by small sample size. No RCT study has ever been done in Hong Kong.&#xD;
&#xD;
      This study can make an important contribution to evidence-based practice by testing the&#xD;
      effectiveness of a smoking cessation intervention using a risk communication approach and&#xD;
      targeting cancer patients. The results primarily serve the purpose to support the development&#xD;
      of clinical practice guidelines and interventions to promote smoking cessation in cancer&#xD;
      patients to improve their cancer prognosis and, in the long-run, increase their survival time&#xD;
      and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The self-reported 7-day point prevalence (pp) quit rate at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Whether the participant has quitted smoking in the past seven days at the time point of 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The self-reported 7-day point prevalence (pp) quit rate at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Whether the participant has quitted smoking in the past seven days at the time point of 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical validation of smoking status at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Biochemically validated quit rate (saliva cotinine level and exhale CO test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients reduced smoking by at least 50% at 6 months</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Percentage of patients reduced smoking by at least 50% at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients reduced smoking by at least 50% at 12 months</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Percentage of patients reduced smoking by at least 50% at 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">528</enrollment>
  <condition>Cancer</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Counseling group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors and a booster intervention (10-15 minutes) at 1 week.&#xD;
Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.Ten subjects from the intervention group who have not quitted will be invited for a process evaluation in the form of face-to-face interviews by research assistants at 12-month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General supporting</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects in this group will receive standard care without risk communication.&#xD;
Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling group</intervention_name>
    <description>Subjects will receive brief advice based on risk communication by a nurse counselor. The brief advice will be based on a specifically-designed risk communication leaflet that warns about the risks of continued smoking for subjects' cancer treatment and prognosis. Subjects will receive a booster intervention via telephone at 1 week to assess the progress of and barriers to the subjects' action plans and identifying individual difficulties and facilitators towards quitting. They also receive a generic standard self-help smoking cessation booklet.</description>
    <arm_group_label>Counseling group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General supporting</intervention_name>
    <description>Subjects in this group will receive a generic self-help smoking cessation booklet and standard care without risk communication. They will have the same follow-up sections as the intervention group to receive diseases support.</description>
    <arm_group_label>General supporting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients smoked at least weekly in the past 6 months;&#xD;
&#xD;
          -  diagnosed with cancer not limited to smoking-induced cancers;&#xD;
&#xD;
          -  patients in all stages 0,I,II,III, or IV;&#xD;
&#xD;
          -  aged 18 or above; and&#xD;
&#xD;
          -  can communicate in Cantonese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those with unstable medical conditions as advised by the doctor in charge;&#xD;
&#xD;
          -  poor cognitive state or with mental illness; and&#xD;
&#xD;
          -  those participating in other smoking cessation program.&#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>Sophia SC Chan, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Benninger MS, Gillen J, Thieme P, Jacobson B, Dragovich J. Factors associated with recurrence and voice quality following radiation therapy for T1 and T2 glottic carcinomas. Laryngoscope. 1994 Mar;104(3 Pt 1):294-8. doi: 10.1288/00005537-199403000-00009.</citation>
    <PMID>8127185</PMID>
  </reference>
  <reference>
    <citation>Browman GP, Wong G, Hodson I, Sathya J, Russell R, McAlpine L, Skingley P, Levine MN. Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):159-63. doi: 10.1056/NEJM199301213280302.</citation>
    <PMID>8417381</PMID>
  </reference>
  <reference>
    <citation>Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. doi: 10.1259/0007-1285-63-751-554.</citation>
    <PMID>2390690</PMID>
  </reference>
  <reference>
    <citation>Chen J, Jiang R, Garces YI, Jatoi A, Stoddard SM, Sun Z, Marks RS, Liu Y, Yang P. Prognostic factors for limited-stage small cell lung cancer: a study of 284 patients. Lung Cancer. 2010 Feb;67(2):221-6. doi: 10.1016/j.lungcan.2009.04.006. Epub 2009 Jun 3.</citation>
    <PMID>19497635</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof. Sophia Siu-chee Chan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cancer patients</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>Risk communication</keyword>
  <!-- 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/NCT01685723
org study id: cancer_rct_1
nct id: NCT01685723
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Background: Smoking cessation can largely improve cancer prognosis and quality of life among
      cancer patients. However, few patients are aware of the importance to quit at the stage, or
      they have difficulties to quit by self.

      Aim: to examine the effectiveness of a smoking cessation intervention using a risk
      communication approach

      Design: A randomized controlled trial

      Setting: Outpatient clinics of the Clinical Oncology Departments of five major hospitals in
      different regions of Hong Kong

      Subject: Smokers who attend medical follow-up visits at outpatient clinics of the Clinical
      Oncology Departments of five major hospitals in different regions of Hong Kong and who met
      the inclusion criteria were invited to participate.

      Intervention: At baseline, intervention group receives:

        1. a face-to-face individualized brief advice based on risk communication for 15-30 minutes
           from the nurse counselors;

        2. examination of exhale CO level; and

        3. a generic standard self-help smoking cessation booklet. They will receive a booster
           intervention at 1 week. Control group will receive standard care and a generic self-help
           smoking cessation booklet.

      Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month
      follow up. Secondary outcomes include:

        1. self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;

        2. biochemically validated quit rate at 6-month follow-up; and

        3. percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up
           compared to baseline.

      Significance: This study develops and validates practical smoking cessation interventions
      targeted to cancer patients to improve their cancer prognosis and in long-term.
Smoking causes many types of cancer in general. Past studies have shown that current smokers
      have increased risk of cancer, and most lung cancers are attributable to smoking. Cancer
      (malignant neoplasm) is the number one killer in Hong Kong, which leads to nearly one-third
      of all deaths each year. Cancer patients who continue smoking would result in extra risks of
      all cause mortality, cancer recurrence and second primary cancer as well as reducing survival
      time (Chen et al., 2010). Smoking could also reduce the efficacy of clinical and medical
      treatment of cancer including radio- and chemo-therapies (Benninger et al., 1994; Browman et
      al., 1993) and increase the risk of treatment related side-effects (Rugg et al., 1990).

      Cancer patients may present an excellent "teachable moment" for smoking cessation
      interventions, as their current illness could largely be due to smoking. However, few smoking
      cessation programs target on this vulnerable group and only one-third of oncology nurses
      would assist cancer patients quit smoking. Healthcare professionals have the responsibility
      to assist this vulnerable group to quit smoking. Recent randomized controlled trials (RCT)
      suggested behavioral intervention may help cancer patients quit smoking, but they are limited
      by small sample size. No RCT study has ever been done in Hong Kong.

      This study can make an important contribution to evidence-based practice by testing the
      effectiveness of a smoking cessation intervention using a risk communication approach and
      targeting cancer patients. The results primarily serve the purpose to support the development
      of clinical practice guidelines and interventions to promote smoking cessation in cancer
      patients to improve their cancer prognosis and, in the long-run, increase their survival time
      and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The self-reported 7-day point prevalence (pp) quit rate at 6 months
time frame: 6 months
description: Whether the participant has quitted smoking in the past seven days at the time point of 6 months
measure: The self-reported 7-day point prevalence (pp) quit rate at 12 months
time frame: 12 months
description: Whether the participant has quitted smoking in the past seven days at the time point of 12 months
measure: Biochemical validation of smoking status at 6 months
time frame: 6 months
description: Biochemically validated quit rate (saliva cotinine level and exhale CO test)
measure: Percentage of patients reduced smoking by at least 50% at 6 months
time frame: Baseline and 6 months
description: Percentage of patients reduced smoking by at least 50% at 6 months
measure: Percentage of patients reduced smoking by at least 50% at 12 months
time frame: Baseline and 12 months
description: Percentage of patients reduced smoking by at least 50% at 12 months
arm group label: Counseling group
arm group type: Experimental
description: Subjects in this group will receive a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors and a booster intervention (10-15 minutes) at 1 week.
Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.Ten subjects from the intervention group who have not quitted will be invited for a process evaluation in the form of face-to-face interviews by research assistants at 12-month follow-up.
arm group label: General supporting
arm group type: Sham Comparator
description: Subjects in this group will receive standard care without risk communication.
Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.
intervention type: Behavioral
intervention name: Counseling group
description: Subjects will receive brief advice based on risk communication by a nurse counselor. The brief advice will be based on a specifically-designed risk communication leaflet that warns about the risks of continued smoking for subjects' cancer treatment and prognosis. Subjects will receive a booster intervention via telephone at 1 week to assess the progress of and barriers to the subjects' action plans and identifying individual difficulties and facilitators towards quitting. They also receive a generic standard self-help smoking cessation booklet.
arm group label: Counseling group
intervention type: Behavioral
intervention name: General supporting
description: Subjects in this group will receive a generic self-help smoking cessation booklet and standard care without risk communication. They will have the same follow-up sections as the intervention group to receive diseases support.
arm group label: General supporting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophia SC Chan, PhD, MPH
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
citation: Benninger MS, Gillen J, Thieme P, Jacobson B, Dragovich J. Factors associated with recurrence and voice quality following radiation therapy for T1 and T2 glottic carcinomas. Laryngoscope. 1994 Mar;104(3 Pt 1):294-8. doi: 10.1288/00005537-199403000-00009.
PMID: 8127185
citation: Browman GP, Wong G, Hodson I, Sathya J, Russell R, McAlpine L, Skingley P, Levine MN. Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):159-63. doi: 10.1056/NEJM199301213280302.
PMID: 8417381
citation: Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. doi: 10.1259/0007-1285-63-751-554.
PMID: 2390690
citation: Chen J, Jiang R, Garces YI, Jatoi A, Stoddard SM, Sun Z, Marks RS, Liu Y, Yang P. Prognostic factors for limited-stage small cell lung cancer: a study of 284 patients. Lung Cancer. 2010 Feb;67(2):221-6. doi: 10.1016/j.lungcan.2009.04.006. Epub 2009 Jun 3.
PMID: 19497635
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Prof. Sophia Siu-chee Chan
investigator title: Professor