Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

NCT ID: NCT00299117

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Breast Cancer; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Research and Development Unit, Herlev Hospital

Principal Investigators

Hanne Tønnesen, MD, PhD

Role: STUDY_CHAIR

WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals

Locations

Brystkirurgisk Afdeling, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Brystkirurgisk Afdeling, Amtssygehuset i Herlev

Copenhagen, Herlev, Denmark

Ringsted Sygehus

Ringsted, Ringsted, Denmark

Countries

Denmark

Other Identifiers

KA-20060007

Identifier Type: -

Identifier Source: org_study_id