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Completed

NCT Number: NCT00299117

Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brystkirurgisk Afdeling, Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief preoperative smoking intervention

Behavioral

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 outcomes

  1. Postoperative complications requiring treatment

    Time frame: 6 months postoperatively

Secondary outcomes

  1. Smoking cessation rates

    Time frame: 12 months postoperatively

  2. Experienced stress and nicotine withdrawal symptoms

    Time frame: 10 days postoperatively

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2006
Registry last updated
Feb 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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