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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00299117 |
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Date of registration:
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03/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Brief Smoking Intervention for Women Undergoing Breast Cancer Surgery
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Scientific title:
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Effect of a Brief Preoperative Smoking Intervention on Postoperative Complications in Women Undergoing Breast Cancer Surgery: A Randomised Clinical Trial |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00299117 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Hanne Tønnesen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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WHO Collaborating Centre for Evidence-Based Health Promotion Hospitals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Smoking
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Intervention(s)
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Behavioral: Brief preoperative smoking intervention
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Primary Outcome(s)
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Postoperative complications requiring treatment
[Time Frame: 6 months postoperatively]
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Secondary Outcome(s)
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Smoking cessation rates
[Time Frame: 12 months postoperatively]
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Experienced stress and nicotine withdrawal symptoms
[Time Frame: 10 days postoperatively]
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Secondary ID(s)
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KA-20060007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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