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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Smoking

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Postoperative complications requiring treatment

Outcome Time Frame:

6 months postoperatively

Safety Issue:

No

Principal Investigator

Hanne T√łnnesen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

KA-20060007

NCT ID:

NCT00299117

Start Date:

April 2006

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Smoking
  • Smoking cessation
  • Stress
  • Nicotine dependence
  • Complication, postoperative
  • Breast Neoplasms
  • Postoperative Complications
  • Smoking

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