Bladder CancerSTOP-OPNCT02188446
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients
A study testing Educational programme for smoking and alcohol cessation in people with Bladder Cancer and Smoking, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Cancer, Smoking, Alcohol Consumption
- What is being tested?
- Educational programme for smoking and alcohol cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Jul 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cancelled operation
- Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
- Pregnant or breastfeeding women
- Mentally incompetent patients
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Urology, University Hospital of Copenhagen
Copenhagen, 2100
About this study
Official title: Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications
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.
Read the detailed description
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
- Bladder Cancer, Smoking, Alcohol Consumption
- Being tested
- Educational programme for smoking and alcohol cessation
- Keywords
- Radical cystectomy, Bladder cancer, Smoking cessation, Alcohol cessation, Postoperative complications
- Medical subject headings
- Urinary Bladder Neoplasms, Smoking, Alcohol Drinking, Smoking Cessation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programme for smoking and alcohol cessationBehavioural
Also called GSP
5 meetings within 6 weeks containing education and pharmacologic support
| Study group | Role | What they receive |
|---|---|---|
| Smoking and alcohol cessation education | Experimental | Not described Receives: Behavioral: Educational programme for smoking and alcohol cessation |
| Standard treatment | No intervention | Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative complications
Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured
Measured: Up to 6 weeks
Secondary outcomes (6)
Postoperative complications
Measured: up to 90 days
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
Measured: Up to 12 months postoperatively
Length of stay
Measured: From day of surgery to day of discharge
Time to return to work or habitual level of activity
Measured: Up to 12 months
Mortality
Measured: Up to 12 months postoperatively
Quality of life ( EORTC QLQ BLM 30 and EQ5D)
Measured: Up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Frederiksberg University Hospital, Aalborg University Hospital, Copenhagen University Hospital at Herlev, Odense University Hospital, Aarhus University Hospital, Karolinska Institutet
- Responsible party
- Principal investigator, Susanne Vahr lauridsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hanne Tønnesen, Professor, Study chair, WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188446
- Sponsor's protocol ID
- F-22841-01
- Acronym
- STOP-OP
- Status last verified
- Jan 2019
- First submitted
- 28 May 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33422365Lauridsen 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.
PubMed 28716147
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications
- ClinicalTrials.gov ID
- NCT02188446
- Acronym / sponsor ID
- STOP-OP / F-22841-01
- Conditions
- Bladder Cancer, Smoking, Alcohol Consumption
- Keywords
- Radical cystectomy, Bladder cancer, Smoking cessation, Alcohol cessation, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Frederiksberg University Hospital, Aalborg University Hospital, Copenhagen University Hospital at Herlev, Odense University Hospital, Aarhus University Hospital, Karolinska Institutet
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Jul 2014 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking and alcohol cessation education | Experimental | Behavioral: Educational programme for smoking and alcohol cessation |
| Standard treatment | No intervention | –Standard treatment is information about benefits of stopping drinking and smoking before surgery and if wanted, advice about who to contact to get support. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Cancelled operation
- Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
- Pregnant or breastfeeding women
- Mentally incompetent patients
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 |
|---|---|---|
| Educational programme for smoking and alcohol cessationAlso: GSP5 meetings within 6 weeks containing education and pharmacologic support | Behavioural | Smoking and alcohol cessation education |
Primary outcome
Number of patients with postoperative complications
Time frame: Up to 6 weeks
Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured
6 secondary outcomes
Postoperative complications
Time frame: up to 90 days
Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation
Time frame: Up to 12 months postoperatively
Length of stay
Time frame: From day of surgery to day of discharge
Time to return to work or habitual level of activity
Time frame: Up to 12 months
Mortality
Time frame: Up to 12 months postoperatively
Quality of life ( EORTC QLQ BLM 30 and EQ5D)
Time frame: Up to 12 months 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 4 Feb 2019.
- Derived from this study: PubMed 33422365Merzaai 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.
- Derived from this study: PubMed 28716147Lauridsen 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.
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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, Professor study chair
WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg University Hospital, DK 2000 Frederiksberg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational programme for smoking and alcohol cessation in people with Bladder Cancer and Smoking, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 4 inclusion and 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients with postoperative complications (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188446, which also lists 2 linked publications.
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 4 Feb 2019.