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CompletedNCT04936568PCRSSUpdated Jul 8, 2025

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

An interventional study of Palliative Care Referral System - PCRS in Advanced Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
380
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

As above.

02

Conditions studied

  • Advanced Cancer

Keywords

  • early palliative care
  • referral
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In context

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • cognitive impairment that would prevent self-assessments
  • current palliative care treatment
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
380 participants (actual)

Study arms

  • No intervention
    control

    standard oncology care

  • Experimental
    intervention

    standardized referral to outpatient palliative care by oncologists

    Other: Palliative Care Referral System - PCRS

Interventions

  • OtherPalliative 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)

06

What researchers measure

Primary outcomes

  1. patient reported experience

    patient satisfaction with care, measured with the FAMCARE-P13

    Time frame: through study completion, up to 6 months

Secondary outcomes

  1. Health related quality of life

    European Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)

    Time frame: through study completion, up to 6 months

  2. caregiver experience of care

    Family Care Satisfaction scale (FAMCARE)

    Time frame: through study completion, up to 6 months

  3. Activation of a Palliative Care service

    Number of regular outpatient Palliative Care visits

    Time frame: through study completion, up to 6 months

  4. Multidisciplinary team visits

    Number of multidisciplinary team visits (Oncology and Palliative Care)

    Time frame: through study completion, up to 6 months

  5. Hospitalization

    Number of hospitalizations

    Time frame: through study completion, up to 6 months

  6. Emergency department accesses

    Number of accesses in Emergency departement

    Time frame: through study completion, up to 6 months

07

Study locations

1 site
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, Milan 20133, Italy
08

References and documents

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. PubMed 36307164 ↗

Individual participant data

Plan to share: No — not planned

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04936568
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Responsible party
Augusto Caraceni (director of Palliative Care Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano) — Principal investigator
First posted
Jun 23, 2021
Start date
Jul 14, 2021
Primary completion
Sep 18, 2024
Completion
Sep 18, 2024
Last update
Jul 8, 2025

Study contacts

Augusto T Caraceni, MD
principal investigator · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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