Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299117
• Other study ID #: KA-20060007
• Status: Completed
• Phase: N/A
• First received: March 3, 2006
• Last updated: January 30, 2009
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Postoperative Complications
• Smoking

Intervention

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.

Locations

Country	Name	City	State
Denmark	Brystkirurgisk Afdeling, Amtssygehuset i Herlev	Copenhagen	Herlev
Denmark	Brystkirurgisk Afdeling, Rigshospitalet	Copenhagen
Denmark	Ringsted Sygehus	Ringsted

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications requiring treatment		6 months postoperatively	No
Secondary	Smoking cessation rates		12 months postoperatively	No
Secondary	Experienced stress and nicotine withdrawal symptoms		10 days postoperatively	No