Skip to main content
Clinical Trials/NCT00299117
NCT00299117
Completed
Not Applicable

Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial

Herlev Hospital3 sites in 1 country130 target enrollmentApril 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Herlev Hospital
Enrollment
130
Locations
3
Primary Endpoint
Postoperative complications requiring treatment
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Postoperative complications requiring treatment

Time Frame: 6 months postoperatively

Secondary Outcomes

  • Smoking cessation rates(12 months postoperatively)
  • Experienced stress and nicotine withdrawal symptoms(10 days postoperatively)

Study Sites (3)

Loading locations...

Similar Trials