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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

March 3, 2006
January 30, 2009
April 2006
December 2008   (final data collection date for primary outcome measure)
Postoperative complications requiring treatment [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
Postoperative complications requiring treatment
Complete list of historical versions of study NCT00299117 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Smoking cessation rates
  • Experienced stress and nicotine withdrawal symptoms
Not Provided
Not Provided
 
Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Breast Cancer
  • Smoking
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00299117
KA-20060007
Yes
Ann M. Møller, Research and Development Unit, Herlev Hospital
Herlev Hospital
Not Provided
Study Chair: Hanne Tønnesen, MD, PhD WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
Herlev Hospital
January 2009

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