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

NCT01367795 | Completed

• 2 other identifiers: EK 10/10EK 2011/070
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Advanced Cancer

Keywords

palliation; quality of life; surgery; surgery; palliative; lifestyle

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks after palliative surgery

Secondary Outcomes (4)

• duration of stay in hospital

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• duration of stay in an intensive care unit

  participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days

• complications

  the participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• reoperations

  the participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (1)

palliative tumor disease

Patients in a known palliative setting with symptoms due to tumor growth.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Kantonsspital Olten: collaborator

Study Sites (2)

Hospital Biel, Department for Surgery

Basel, Basel, 2501, Switzerland

Location

Kantonsspital Olten, Department for Surgery

Olten, Canton of Solothurn, 4460, Switzerland

Location

Study Officials

• Carsten T. Viehl, MD

  Department of Surgery, University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: June 7, 2011
• Study Start: July 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

CH (2)