Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

January 30, 2009 updated by: Herlev Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Brief preoperative smoking intervention

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Copenhagen, Denmark, 2100
    - Brystkirurgisk Afdeling, Rigshospitalet
  - Ringsted, Denmark, 4100
    - Ringsted Sygehus
- Herlev
  - Copenhagen, Herlev, Denmark, 2730
    - Brystkirurgisk Afdeling, Amtssygehuset i Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative complications requiring treatment Time Frame: 6 months postoperatively	6 months postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

Study Chair: Hanne Tønnesen, MD, PhD, WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)