Clinical trial NCT00299117: Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
Official title: Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Smoking
Keywords: Smoking cessation
Stress
Nicotine dependence
Complication, postoperative
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2006-03-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Postoperative complications requiring treatment
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Smoking cessation rates
timeFrame: 12 months postoperatively
measure: Experienced stress and nicotine withdrawal symptoms
timeFrame: 10 days postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Brystkirurgisk Afdeling, Amtssygehuset i Herlev
state: Herlev
city: Copenhagen
country: Denmark
facility: Brystkirurgisk Afdeling, Rigshospitalet
city: Ringsted
country: Denmark
facility: Ringsted Sygehus
Study officials:
affiliation: WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
name: Hanne Tønnesen, MD, PhD
role: STUDY_CHAIR
References: