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

Study Overview
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Brief Summary
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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
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As above.

Official Title
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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.

Conditions
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Advanced Cancer

Intervention / Treatment
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* Other: Palliative Care Referral System - PCRS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early palliative care, referral