Breast CancerNCT00299117
Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
A study testing Brief preoperative smoking intervention in people with Breast Cancer and Smoking, run by Herlev Hospital at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Smoking
- What is being tested?
- Brief preoperative smoking intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 3 sitesDenmark
- Study dates
- Apr 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman
- Scheduled for elective breast cancer surgery
- Daily smoker
- Age 18 years and above
- Able to read and write Danish
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Brystkirurgisk Afdeling, Rigshospitalet
Copenhagen, Copenhagen, 2100
Brystkirurgisk Afdeling, Amtssygehuset i Herlev
Copenhagen, Herlev, 2730
Ringsted Sygehus
Ringsted, Ringsted, 4100
About this study
Official title: 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.
Read the 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
- Being tested
- Brief preoperative smoking intervention
- Keywords
- Smoking cessation, Stress, Nicotine dependence, Complication, postoperative
- Medical subject headings
- Breast Neoplasms, Smoking, Smoking Cessation, Tobacco Use Disorder, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief preoperative smoking interventionBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications requiring treatment
Measured: 6 months postoperatively
Secondary outcomes (2)
Smoking cessation rates
Measured: 12 months postoperatively
Experienced stress and nicotine withdrawal symptoms
Measured: 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hanne Tønnesen, MD, PhD, Study chair, WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299117
- Sponsor's protocol ID
- KA-20060007
- Status last verified
- Jan 2009
- First submitted
- 3 Mar 2006
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00299117
- Acronym / sponsor ID
- KA-20060007
- Conditions
- Breast Cancer, Smoking
- Keywords
- Smoking cessation, Stress, Nicotine dependence, Complication, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman
- Scheduled for elective breast cancer surgery
- Daily smoker
- Age 18 years and above
- Able to read and write Danish
Key exclusion criteria (6 listed)
- Alcohol intake >35 units per week
- Diagnosed psychiatric disease (including substance abuse and dementia)
- ASA IV and V
- Preoperative neo-adjuvant chemotherapy
- Ulcerating cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief preoperative smoking interventionOne 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. | Behavioural | – |
Primary outcome
Postoperative complications requiring treatment
Time frame: 6 months postoperatively
2 secondary outcomes
Smoking cessation rates
Time frame: 12 months postoperatively
Experienced stress and nicotine withdrawal symptoms
Time frame: 10 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Tønnesen, MD, PhD study chair
WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief preoperative smoking intervention in people with Breast Cancer and Smoking, run by Herlev Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications requiring treatment (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2009; AzTrials last refreshed its copy on 7 Nov 2026.