Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kantonsspital Olten
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01367795
First received: July 14, 2010
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition
Advanced Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Quality of life 4 weeks after palliative surgery [ Time Frame: 4 weeks after palliative surgery ] [ Designated as safety issue: No ]
    Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).


Secondary Outcome Measures:
  • duration of stay in hospital [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • complications [ Time Frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    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.

  • reoperations [ Time Frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
palliative tumor disease
Patients in a known palliative setting with symptoms due to tumor growth.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367795

Contacts
Contact: Anke M. Mols, MD +41 62 311 5148 anke.mols@spital.so.ch
Contact: Carsten T. Viehl, MD +41 61 265 71 88 ViehlC@uhbs.ch

Locations
Switzerland
Kantonsspital Olten, Department for Surgery Recruiting
Olten, Solothurn, Switzerland, 4460
Contact: Anke M Mols, MD    0041 62 311 5148    anke.mols@spital.so.ch   
Contact: Markus M Zuber, Professor    0041 62 311 4230    markus.zuber@spital.so.ch   
University Hospital of Basel, Department for Surgery Recruiting
Basel, Switzerland, 4310
Contact: Carsten T Viehl, MD    0041 61 265 2525    viehlc@uhbs.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Olten
Investigators
Principal Investigator: Carsten T. Viehl, MD Department of Surgery, University Hospital of Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01367795     History of Changes
Other Study ID Numbers: EK 10/10, EK 2011/070
Study First Received: July 14, 2010
Last Updated: April 10, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
palliation
quality of life
surgery
surgery; palliative
lifestyle

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014