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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief preoperative smoking intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications requiring treatment | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation rates | 12 months postoperatively | |
| Experienced stress and nicotine withdrawal symptoms | 10 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Tønnesen, MD, PhD | WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brystkirurgisk Afdeling, Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark | ||
| Brystkirurgisk Afdeling, Amtssygehuset i Herlev |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Copenhagen |
| Herlev |
| 2730 |
| Denmark |
| Ringsted Sygehus | Ringsted | Ringsted | 4100 | Denmark |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |