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

NCT04936568 | Completed

• 1 other identifier: 201/19
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

early palliative care; referral

Outcome Measures

Primary Outcomes (1)

• patient reported experience

  patient satisfaction with care, measured with the FAMCARE-P13

  through study completion, up to 6 months

Secondary Outcomes (6)

• Health related quality of life

  through study completion, up to 6 months

• caregiver experience of care

  through study completion, up to 6 months

• Activation of a Palliative Care service

  through study completion, up to 6 months

• Multidisciplinary team visits

  through study completion, up to 6 months

• Hospitalization

  through study completion, up to 6 months

Study Arms (2)

control

NO INTERVENTION

standard oncology care

intervention

EXPERIMENTAL

standardized referral to outpatient palliative care by oncologists

Other: Palliative Care Referral System - PCRS

Interventions

Palliative Care Referral System - PCRS OTHER

Implementation of a system to help oncologists to identify criteria for referring patients to specialized outpatient palliative care (Palliative Care Referral System - PCRS)

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

Location

Related Publications (1)

• 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.

  PMID: 36307164 DERIVED

Study Officials

• Augusto T Caraceni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Palliative Care Unit

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 23, 2021
• Study Start: July 14, 2021
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)