Viewing Study NCT04936568


Ignite Creation Date: 2025-12-24 @ 5:39 PM
Ignite Modification Date: 2025-12-28 @ 1:01 PM
Study NCT ID: NCT04936568
Status: COMPLETED
Last Update Posted: 2025-07-08
First Post: 2021-06-08
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Organization:

Study Overview

Official Title: Implementation of a Standardized Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease: Impact on Patient and Caregiver Satisfaction With Care and Use of Health Care Resources.
Status: COMPLETED
Status Verified Date: 2025-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PCRSS
Brief Summary: Early palliative care (EPC) in the clinical pathway of advanced cancer patients improves symptom control, quality of life and has a positive impact on overall quality of care. EPC contributes to realistic and attainable goals of treatment, facilitating patient choices, favouring adequate communication with patients and families and assessing patient values and preferences with regard to advance care planning. EPC is likely to promote a more appropriate use of health care resources and less aggressive cancer treatment in the last weeks of life. At present standardised criteria for appropriate referral for EPC in oncology outpatients setting are lacking. Therefore the aim of this project is to identify referral criteria and procedures to implement appropriate EPC for advanced patients (the Palliative Care Referral System) and test them in a pre-post experimental design evaluating their impact on quality of care and on the use of healthcare resources. A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics of a Comprehensive Cancer Centre. Eligible patients will undergo patient-reported outcome measure (PROMs) evaluation at baseline and then monthly for at least 6 months from enrollment or till death. Use health care resources and quality of care indicators will be collected monthly by a dedicated research nurse.
Detailed Description: As above.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: