Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

NCT ID: NCT02188446

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.

Conditions

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Bladder Cancer Smoking Alcohol Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smoking and alcohol cessation education

Group Type EXPERIMENTAL

Educational programme for smoking and alcohol cessation

Intervention Type BEHAVIORAL

5 meetings within 6 weeks containing education and pharmacologic support

Standard treatment

Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational programme for smoking and alcohol cessation

5 meetings within 6 weeks containing education and pharmacologic support

Intervention Type BEHAVIORAL

Other Intervention Names

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GSP

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years scheduled for cystectomy due to bladder cancer
* Daily smoker or/and intake of

-\>21 units (252 g) of alcohol pr week
* Informed consent

Exclusion Criteria

* Cancelled operation
* Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
* Pregnant or breastfeeding women
* Mentally incompetent patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Susanne Vahr lauridsen

MEd, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanne Tønnesen, Professor

Role: STUDY_CHAIR

WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark

Locations

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Department of Urology, University Hospital of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Merzaai B, Tonnesen H, Rasmussen M, Lauridsen SV. Perioperative Alcohol and Smoking Cessation Intervention: Impact on Other Lifestyles. Semin Oncol Nurs. 2021 Feb;37(1):151116. doi: 10.1016/j.soncn.2020.151116. Epub 2021 Jan 6.

Reference Type DERIVED
PMID: 33422365 (View on PubMed)

Lauridsen SV, Thomsen T, Thind P, Tonnesen H. STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. Trials. 2017 Jul 17;18(1):329. doi: 10.1186/s13063-017-2065-6.

Reference Type DERIVED
PMID: 28716147 (View on PubMed)

Related Links

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Other Identifiers

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F-22841-01

Identifier Type: -

Identifier Source: org_study_id

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