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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04936568
Acronym
PCRSS
Enrollment
380
Registered
2021-06-23
Start date
2021-07-14
Completion date
2024-09-18
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Keywords

early palliative care, referral

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.

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)

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
patient reported experiencethrough study completion, up to 6 monthspatient satisfaction with care, measured with the FAMCARE-P13

Secondary

MeasureTime frameDescription
caregiver experience of carethrough study completion, up to 6 monthsFamily Care Satisfaction scale (FAMCARE)
Activation of a Palliative Care servicethrough study completion, up to 6 monthsNumber of regular outpatient Palliative Care visits
Health related quality of lifethrough study completion, up to 6 monthsEuropean Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)
Hospitalizationthrough study completion, up to 6 monthsNumber of hospitalizations
Emergency department accessesthrough study completion, up to 6 monthsNumber of accesses in Emergency departement
Multidisciplinary team visitsthrough study completion, up to 6 monthsNumber of multidisciplinary team visits (Oncology and Palliative Care)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026