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Completed

NCT Number: NCT04936568

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

About this study

As above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. patient reported experience

    Time frame: through study completion, up to 6 months

    patient satisfaction with care, measured with the FAMCARE-P13

Secondary outcomes

  1. Health related quality of life

    Time frame: through study completion, up to 6 months

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

  2. caregiver experience of care

    Time frame: through study completion, up to 6 months

    Family Care Satisfaction scale (FAMCARE)

  3. Activation of a Palliative Care service

    Time frame: through study completion, up to 6 months

    Number of regular outpatient Palliative Care visits

  4. Multidisciplinary team visits

    Time frame: through study completion, up to 6 months

    Number of multidisciplinary team visits (Oncology and Palliative Care)

  5. Hospitalization

    Time frame: through study completion, up to 6 months

    Number of hospitalizations

  6. Emergency department accesses

    Time frame: through study completion, up to 6 months

    Number of accesses in Emergency departement

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study 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.

Acronym: PCRSS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2021
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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