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

Not Applicable

Recruiting

• Conditions: Advanced Cancer
• Interventions: Other: Palliative Care Referral System - PCRS

• Registration Number: NCT04936568
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Study Start: 2021-07-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Palliative Care Referral System - PCRS	standardized referral to outpatient palliative care by oncologists

Primary Outcome Measures

Name	Time	Method
patient reported experience	through study completion, up to 6 months	patient satisfaction with care, measured with the FAMCARE-P13

Secondary Outcome Measures

Name	Time	Method
Hospitalization	through study completion, up to 6 months	Number of hospitalizations
caregiver experience of care	through study completion, up to 6 months	Family Care Satisfaction scale (FAMCARE)
Activation of a Palliative Care service	through study completion, up to 6 months	Number of regular outpatient Palliative Care visits
Health related quality of life	through study completion, up to 6 months	European Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)
Multidisciplinary team visits	through study completion, up to 6 months	Number of multidisciplinary team visits (Oncology and Palliative Care)
Emergency department accesses	through study completion, up to 6 months	Number of accesses in Emergency departement

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy