Advanced CancerNCT01367795
Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
An observational study of Advanced Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- How many people
- 26 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2010to Oct 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in a known tumorrelated palliative situation will be included when an operation is discussed for relieve of symptomatic localised tumor growth . Patients will be recruited from clinics or the emergency room.
Who may be able to join
- informed consent
- tumor patients within a known palliative situation, patients do know about the absence of a curative treatment
- patients are symptomatic because of localized tumor growth
- patients having an operation for symptom relief or treated without surgery
Who cannot join
- patients with an only intraoperatively seen palliative tumor disease
- debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)
- dementia, age ≤ 18, barrier of speech
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Hospital Biel, Department for Surgery
Basel, Basel, 2501
Kantonsspital Olten, Department for Surgery
Olten, Canton of Solothurn, 4460
About this study
Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.
Read the detailed description
What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.
By the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.
The questionnaire will be completed after 4 and 12 weeks as well.
- Conditions
- Advanced Cancer
- Keywords
- palliation, quality of life, surgery, surgery; palliative, lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| palliative tumor disease | Patients in a known palliative setting with symptoms due to tumor growth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life 4 weeks after palliative surgery
Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).
Measured: 4 weeks after palliative surgery
Secondary outcomes (4)
duration of stay in hospital
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
duration of stay in an intensive care unit
Measured: participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days
complications
Complications will be recorded following the Clavien-Dindo classification of surgical complications. This 5-scale classification is based on the type of therapy needed to correct the complications.
Measured: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
reoperations
The need for reoperations is generally part of the 5-class complication scale by Clavien and Dindo, which we are using to record complications. Reoperations (class IIIb in the classification of complications) are recorded seperately.
Measured: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Olten
- Responsible party
- Sponsor
- Investigators
- Carsten T. Viehl, MD, Principal investigator, Department of Surgery, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367795
- Sponsor's protocol ID
- EK 10/10
- Other IDs
- EK 2011/070
- Status last verified
- Mar 2015
- First submitted
- 14 Jul 2010
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
- ClinicalTrials.gov ID
- NCT01367795
- Acronym / sponsor ID
- EK 10/10
- Conditions
- Advanced Cancer
- Keywords
- palliation, quality of life, surgery, surgery; palliative, lifestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Olten
- Study start
- Jul 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Jun 2011 (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.
Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.
Detailed description
What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.
By the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.
The questionnaire will be completed after 4 and 12 weeks as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palliative tumor disease | – | –Patients in a known palliative setting with symptoms due to tumor growth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a known tumorrelated palliative situation will be included when an operation is discussed for relieve of symptomatic localised tumor growth . Patients will be recruited from clinics or the emergency room.
Key inclusion criteria (4 listed)
- informed consent
- tumor patients within a known palliative situation, patients do know about the absence of a curative treatment
- patients are symptomatic because of localized tumor growth
- patients having an operation for symptom relief or treated without surgery
Key exclusion criteria (3 listed)
- patients with an only intraoperatively seen palliative tumor disease
- debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)
- dementia, age ≤ 18, barrier of speech
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life 4 weeks after palliative surgery
Time frame: 4 weeks after palliative surgery
Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).
4 secondary outcomes
duration of stay in hospital
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
duration of stay in an intensive care unit
Time frame: participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days
complications
Time frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
reoperations
Time frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 27 Mar 2015.
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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.
Carsten T. Viehl, MD principal investigator
Department of Surgery, University Hospital of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 3 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Quality of life 4 weeks after palliative surgery (time frame: 4 weeks after palliative surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2015.