Metastatic Cancer Clinical Trial
Official title:
Accuracy of a New Simplified Screening Tool in Identifying the In-hospital Patients in Need of Palliative Care
Every day many patients affected by chronic life-limiting illnesses are admitted into
Internal Medicine wards, coming from the Emergency Department. Many studies suggest that
providing palliative care to these patients may improve their end-of-life care while reducing
costs by minimizing futile treatments and unwanted intensive care unit admissions.
Consequently, there is a strong need for acute care hospitals to more vigorously identify
patients entering the final phase of their lives as well as their specific care needs.
In a previous study the investigators screened for need of palliative care patients affected
by progressive chronic diseases by means of a tool, based on the Italian Society of
Anesthesia, Analgesia, Resuscitation, and Intensive Care - SIAARTI - position paper reporting
criteria for patients with end-stage chronic organ failures, and on the specific clinical
indicators elaborated by the National Comprehensive Cancer Network (NCCN) for patients with
locally advanced/metastatic cancer. In a further pilot study, the investigators compared the
outcomes of PC patients depending on whether the palliative care team evaluated such patients
only if requested by the physician staff or routinely, irrespectively of a specific request,
finding a significant increase of discharges after the activation of an appropriate PC
service or scheduled PC ambulatory visit.
In the present study the investigators enroll chronically ill patients admitted to an
Internal Medicine Unit from the Emergency Department, to be screened for palliative care
need, using the previously cited SIAARTI/NCCN screening tool (Extended Screening Tool - EST),
or using a Simplified Screening Tool (SST), derived from the first instrument, which
preliminary showed a superimposable efficacy. This latter tool has advantages related to much
more shortness and therefore simplicity in the administration to a seriously ill patient and
is much less time consuming, allowing the physician to use it routinely.
The aim of the study is to verify the accuracy of the SST in identifying chronically ill
patients in need of a PC approach, in comparison to the SIAARTI/NCCN tool (EST). If the SST
would show good accuracy, an easily manageable tool for the assessment of PC needs in
chronically ill patients would be available for the daily routine.
Due to population aging and advances in medicine and public health, the prevalence of people
affected by progressive, chronic, life-limiting diseases is increasing. Many studies
documented that patients with progressive chronic diseases received care that was more aimed
at the prolongation of life than palliation of symptoms during their last 6-12 months of
life, as well as frequent hospitalizations. These data suggested that providing palliative
care (PC) to these patients may improve their end-of-life care while reducing costs by
minimizing futile treatments and unwanted ICU care.
Consequently, there is a strong need for acute care hospitals to more vigorously identify
patients entering the final phase of their lives as well as their specific care needs.
Historically, Hospice and PC services have focused on the needs of cancer patients. However,
the majority of patients needing PC worldwide suffer from life-limiting non-cancer illnesses,
like cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal failure,
cirrhosis of the liver, Alzheimer's and other dementias, multiple sclerosis, Parkinson's
disease, HIV/AIDS, rheumatoid arthritis, and diabetes. The main illnesses requiring PC are
cardiovascular diseases (38%), cancer (34%), and COPD (10%).
In order to correctly identify such patients, adequate screening tools are needed.
In a previous study, the investigators employed for this aim a screening tool derived from
the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI)
position paper based on expert panel opinions reporting criteria to identify patients with
end-stage chronic organ failures. For cancer patients, the screening was done according to
specific clinical indicators elaborated by the National Comprehensive Cancer Network (NCCN).
A Simplified Screening Tool was also created, in order to make available an easier instrument
for the same aim.
The SIAARTI/NCCN screening tool (Extended Screening Tool - EST) is, in fact, an instrument
validated by many scientific societies, but it is very articulated and its compilation is too
much time-consuming. The Simplified Screening Tool (SST) has been created through a
statistical process in order to include all the critical variables, with the advantage of
being shorter and therefore easier to administer in a routinely use.
The aim of the current study is to demonstrate that the SST has accuracy comparable to that
of the SIAARTI/NCCN tool in identifying chronically ill patients in need of a PC approach,
thus making available an easily manageable tool for the assessment of PC needs in chronically
ill patients.
In order to do this, every enrolled patient will be administered both the SST and the
SIAARTI/NCCN tool, in a randomized sequence.
After completion of the enrollment and data collection, an appropriate statistical
methodology will be employed for the comparison between the established SIAARTI/NCCN tool and
the SST.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Recruiting |
NCT05798611 -
Study of ART0380 in Patients With Biologically Selected Solid Tumors
|
Phase 2 | |
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05036681 -
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
|
Phase 2 | |
Withdrawn |
NCT00005030 -
SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
|
Phase 1 | |
Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
Recruiting |
NCT04085029 -
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
|
||
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05981170 -
Rurality Adapted Physical Activity Sport Health
|
||
Not yet recruiting |
NCT03058809 -
Evaluation of Viatarâ„¢ Oncopheresis System in Removing CTC From Whole Blood
|
Phase 1/Phase 2 | |
Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01302808 -
Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
Terminated |
NCT00918645 -
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
|
N/A | |
Completed |
NCT00795678 -
Chemotherapeutic Agents in Brain/Breast
|
N/A | |
Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
Completed |
NCT00557102 -
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
|
Phase 2 | |
Recruiting |
NCT00398437 -
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
|
N/A |