Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease (PCRSS)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Palliative Care Referral System - PCRS

Detailed Description

As above.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age >18 years;
• recent diagnosis of inoperable locally advanced and/or metastatic cancer not eligible to anticancer treatment with curative intent;

Exclusion Criteria:

• cognitive impairment that would prevent self-assessments
• current palliative care treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; standard oncology care
Experimental: intervention; standardized referral to outpatient palliative care by oncologists	Other: Palliative Care Referral System - PCRS; Implementation of a system to help oncologists to identify criteria for referring patients to specialized outpatient palliative care (Palliative Care Referral System - PCRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient reported experience	patient satisfaction with care, measured with the FAMCARE-P13	through study completion, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	European Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)	through study completion, up to 6 months
caregiver experience of care	Family Care Satisfaction scale (FAMCARE)	through study completion, up to 6 months
Activation of a Palliative Care service	Number of regular outpatient Palliative Care visits	through study completion, up to 6 months
Multidisciplinary team visits	Number of multidisciplinary team visits (Oncology and Palliative Care)	through study completion, up to 6 months
Hospitalization	Number of hospitalizations	through study completion, up to 6 months
Emergency department accesses	Number of accesses in Emergency departement	through study completion, up to 6 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications and helpful links

General Publications

• Brunelli C, Zecca E, Pigni A, Bracchi P, Caputo M, Lo Dico S, Fusetti V, Tallarita A, Bergamini C, Brambilla M, Raimondi A, Niger M, Provenzano S, Sepe P, Alfieri S, Tine G, De Braud F, Caraceni AT. Outpatient palliative care referral system (PCRS) for patients with advanced cancer: an impact evaluation protocol. BMJ Open. 2022 Oct 28;12(10):e059410. doi: 10.1136/bmjopen-2021-059410.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: referral; early palliative care
• Other Study ID Numbers: 201/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No