Advanced Incurable Cancer Clinical Trial
Official title:
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.
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.
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