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Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

This study has been completed.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00299117
First received: March 3, 2006
Last updated: January 30, 2009
Last verified: January 2009
History of Changes
  Purpose

The primary purpose of this study is to examine the effect of a brief preoperative smoking intervention on postoperative complications in women undergoing breast cancer surgery.

Secondary purposes are to examine long-term smoking cessation rates and experienced stress and nicotine withdrawal symptoms during the smoking cessation period.


Condition Intervention
Breast Cancer
Smoking
 Behavioral: Brief preoperative smoking intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Postoperative complications requiring treatment [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking cessation rates [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Experienced stress and nicotine withdrawal symptoms [ Time Frame: 10 days postoperatively ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Brief preoperative smoking intervention
    One counseling session of approximately 45 minutes duration 3-4 days preoperatively. The intervention is inspired by the principles of motivational interviewing and The Stages of Change Model.
Detailed Description:

Smokers are at greater risk of developing postoperative complications. The connection between smoking and cardiovascular and pulmonary disease is furthermore well documented.

Smoking cessation 6 weeks before orthopaedic surgery significantly reduces the risk of developing postoperative complications. However, smoking cessation for an even shorter period may theoretically have similar effects on postoperative complications.

Intensive smoking intervention programmes increase long-term smoking cessation rates significantly. Little evidence is available on the efficacy of brief smoking intervention programmes for newly diagnosed cancer patients.

This study therefore aims to examine the effect of a brief smoking intervention on postoperative complications and long-term smoking cessation rates in women undergoing breast cancer surgery.

The study is a randomised clinical trial in which study participants are randomised by block randomisation to either standard care (control group) or a brief preoperative smoking intervention (intervention group). Patients in the intervention group are counselled to comply with an intended perioperative smoking cessation period of 13 days.

The intervention and control groups will be compared up to 12 months postoperatively in regard to frequency of postoperative complications and smoking cessation rates. Additionally, experienced stress and nicotine withdrawal symptoms during the perioperative smoking cessation period will be compared between the groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman
  • Scheduled for elective breast cancer surgery
  • Daily smoker
  • Age 18 years and above
  • Able to read and write Danish
  • Informed consent.

Exclusion Criteria:

  • Alcohol intake >35 units per week
  • Diagnosed psychiatric disease (including substance abuse and dementia)
  • ASA IV and V
  • Preoperative neo-adjuvant chemotherapy
  • Ulcerating cancer
  • Pregnancy and breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299117

Locations
Denmark
Brystkirurgisk Afdeling, Amtssygehuset i Herlev
Copenhagen, Herlev, Denmark, 2730
Brystkirurgisk Afdeling, Rigshospitalet
Copenhagen, Denmark, 2100
Ringsted Sygehus
Ringsted, Denmark, 4100
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Chair: Hanne Tønnesen, MD, PhD WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
  More Information

No publications provided

Responsible Party: Ann M. Møller, Research and Development Unit, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00299117     History of Changes
Other Study ID Numbers: KA-20060007
Study First Received: March 3, 2006
Last Updated: January 30, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
Smoking cessation
Stress
Nicotine dependence
Complication, postoperative

Additional relevant MeSH terms:
Breast Neoplasms
Postoperative Complications
Smoking
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Pathologic Processes
Habits

ClinicalTrials.gov processed this record on May 23, 2013