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Trial record 1 of 1 for:    NCT01320462
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Smoking Cessation Program in the Preadmission Clinic

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ClinicalTrials.gov Identifier: NCT01320462
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE March 21, 2011
First Posted Date  ICMJE March 22, 2011
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
pre-surgery counseling for quit smoking [ Time Frame: 1 year after surgery ]
In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:
  • Have you been abstinent from smoking for the past four weeks? (4-week abstinence)
  • Do you currently smoke cigarettes everyday? (point prevalence)
  • Have you been abstinent from smoking since the last time you quit smoking? (continuous abstinence)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
perioperative complications [ Time Frame: 3 months after surgery ]
Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date. The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Program in the Preadmission Clinic
Official Title  ICMJE Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Brief Summary

Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates

Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE
  • Drug: Smoking cessation counselling group
    The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
  • Other: Control group:
    Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
Study Arms  ICMJE
  • Experimental: Smoking cessation group
    Counselling, Pharmacotherapy and Smokers Help Line
    Intervention: Drug: Smoking cessation counselling group
  • Control group
    Brief informatin about quitting and smokers help line
    Intervention: Other: Control group:
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2011)
296
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who smoke more than 10 cigarettes per day for more than 1 year
  • And had no period of smoking abstinence longer than 3 months in the past year.
  • Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age

Exclusion Criteria:

  • Patients unwilling or unable to give informed consent
  • Patients who are pregnant and breast feeding
  • Patients with any psychiatric disorder
  • Patients who used nicotine replacement / bupropion within previous 3 months
  • Cardiovascular disease within the past 6 months
  • Any serious or unstable disease within the past 6 months
  • Drug or alcohol abuse within the past year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01320462
Other Study ID Numbers  ICMJE WS836526
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Frances Chung, FRCPC University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP