Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Smoking

Intervention / Treatment
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* Behavioral: Brief preoperative smoking intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications requiring treatment |  | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rates |  | 12 months postoperatively | 
| Experienced stress and nicotine withdrawal symptoms |  | 10 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Stress, Nicotine dependence, Complication, postoperative