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

No results posted yet for this study

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

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
  • Karolinska Institutet

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188446 on ClinicalTrials.gov