Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
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.
|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|
- Postoperative complications requiring treatment [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Behavioral: Brief preoperative smoking intervention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299117
|Brystkirurgisk Afdeling, Amtssygehuset i Herlev|
|Copenhagen, Herlev, Denmark, 2730|
|Brystkirurgisk Afdeling, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Ringsted, Denmark, 4100|
|Study Chair:||Hanne Tønnesen, MD, PhD||WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals|