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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299117

Enrollment

130

Registered

2006-03-06

Start date

2006-04-30

Completion date

2008-12-31

Last updated

2009-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Smoking

Keywords

Smoking cessation, Stress, Nicotine dependence, Complication, postoperative

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.

Interventions

BEHAVIORALBrief 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Postoperative complications requiring treatment	6 months postoperatively

Secondary

Measure	Time frame
Smoking cessation rates	12 months postoperatively
Experienced stress and nicotine withdrawal symptoms	10 days postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026