Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT00299117|
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : February 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Smoking||Behavioral: Brief preoperative smoking intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- 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.
- Postoperative complications requiring treatment [ Time Frame: 6 months postoperatively ]
- Smoking cessation rates [ Time Frame: 12 months postoperatively ]
- Experienced stress and nicotine withdrawal symptoms [ Time Frame: 10 days postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|