Romanian-Swiss Research Programme IZERZO (IZERZO)

July 31, 2017 updated by: Florian Strasser, MD ABHPM, Cantonal Hospital of St. Gallen

Reality Map of Integrated Oncology and Palliative Care in Romanian and Swiss Cancer Centres

Palliative Care procedures should be integrated early in the course of disease of patients with advanced incurable cancer. With this study, where the investigators follow adult patients with incurable cancer over 6 months or until death (whatever occurs earlier), the investigators aim to identify patients' needs for Palliative Care interventions (like support in illness understanding and decision making, symptom management, concrete end-of-life preparation, and others) and their remembered delivery by health care professionals. The investigators also collect data on patients care (use of chemotherapy, intensive care in the last month of life) and quality of death and dying (assessed by post-death-interviews with bereaved relatives). The aim is to have a "reality map" on current integration of oncology and palliative care and to test if appropriate Palliative Care interventions predict a better outcome.

Study Overview

Status

Completed

Conditions

Detailed Description

Background The integration of Palliative Care (PC) in routine oncological care remains challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal disperse settings like Romania. The investigators aim to collect original data ("reality map") about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and specific outcome quality indicators (QI). The investigators also hypothesize that both predefined cofactors and appropriately delivered KI-PCC will predict quality of care.

Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in this setting there are no predefined structures, the investigators focus on interventions perceived by the patient.

Methods The investigators' target population are advanced incurable cancer patients in different care settings (oncology clinics, Palliative Care centers, and hospice, varying in size, location (rural, urban) and grade of specialization) representing the heterogeneity of care in Romania. The investigators characterize the population using demographic data (EAPC basic dataset amended by country specific data like family structures and income), and validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These KI-PCC include illness understanding, symptom management, decision making, spirituality, end-of-life-preparation, and network/family support. Further, the investigators collect defined outcome quality indicators (QI) for the integration (quality of death and dying, symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In addition, known, associated cofactors (e.g. comorbidities, living situation) are measured. The data collection will be longitudinal with monthly follow-ups for at most six months or until death. Focus groups at each participating center explore local influencing factors both for KI-PCC and QI. Several steps of quality assurance (source data verification, expert reviews of anticancer treatment, etc.) are introduced.

The analysis has three elements. First, the investigators will describe the population. Second, the investigators will map the patient perceived KI-PCC and defined outcome QI. Third, if data show robust after international expert review, the investigators will test the hypothesis that appropriate KI-PCC predict quality of care, measured by QI.

Expected impact The investigators expect that their approach will identify gaps in the integration of oncology and palliative care in their specific settings, focusing, however, mainly on patient and proxy view and backed by available information from outcome QI. The conduct of this protocol might also directly have an influence on patient care.

This approach will allow the development of tailored interventions in a next step. The investigators' approach may also serve as a model to measure the integration of oncology and palliative care in various settings, focusing on interventions.

Study Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Cluj, Romania
        • Oncological Institute "Prof. Dr. Ion Chiricuta"
  • Switzerland
      • St.Gallen, Switzerland
        • Kantonsspital St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced, incurable cancer patients, adult, without cognitive impairment, with a minimal symptom burden (defined threshold on IPOS)

Description

Inclusion Criteria:

  • stage IV cancer
  • over 18 years
  • minimal symptom burden in IPOS (at least 3 symptoms over or equal 2)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 1, 2, 3

Exclusion Criteria:

  • cognitively impaired
  • prognosis less than 1 month according to clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint
Time Frame: up to 6 months (or death, whichever occurs first)
A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), "aggressive" end-of-life-care, and bad quality of death and dying (QODD)
up to 6 months (or death, whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Florian Strasser, MD, Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKSG 13/157
  • IZERZO_142226/1 (Other Grant/Funding Number: Swiss National Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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