Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients
NCT02188446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2019-02-04
Summary
Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.
Conditions
- Bladder Cancer
- Smoking
- Alcohol Consumption
Interventions
- BEHAVIORAL
-
Educational programme for smoking and alcohol cessation
5 meetings within 6 weeks containing education and pharmacologic support
Sponsors & Collaborators
-
Frederiksberg University Hospital
collaborator OTHER -
Aalborg University Hospital
collaborator OTHER -
Copenhagen University Hospital at Herlev
collaborator OTHER -
Odense University Hospital
collaborator OTHER -
Aarhus University Hospital
collaborator OTHER - collaborator OTHER
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Hanne Tønnesen, Professor · WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2018-07-31
- Completion
- 2018-07-31
Countries
- Denmark
Study Locations
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