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Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

Primary Purpose

Breast Cancer, Smoking

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Brief preoperative smoking intervention
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Smoking cessation, Stress, Nicotine dependence, Complication, postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Brystkirurgisk Afdeling, Amtssygehuset i Herlev
  • Brystkirurgisk Afdeling, Rigshospitalet
  • Ringsted Sygehus

Outcomes

Primary Outcome Measures

Postoperative complications requiring treatment

Secondary Outcome Measures

Smoking cessation rates
Experienced stress and nicotine withdrawal symptoms

Full Information

First Posted
March 3, 2006
Last Updated
January 30, 2009
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00299117
Brief Title
Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
Official Title
Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Smoking
Keywords
Smoking cessation, Stress, Nicotine dependence, Complication, postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Brief preoperative smoking intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complications requiring treatment
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Smoking cessation rates
Time Frame
12 months postoperatively
Title
Experienced stress and nicotine withdrawal symptoms
Time Frame
10 days postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Tønnesen, MD, PhD
Organizational Affiliation
WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Brystkirurgisk Afdeling, Amtssygehuset i Herlev
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Brystkirurgisk Afdeling, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Ringsted Sygehus
City
Ringsted
ZIP/Postal Code
4100
Country
Denmark

12. IPD Sharing Statement

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Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

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