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

Advanced Cancer Clinical Trial

— PCRSS  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936568
• Other study ID #: 201/19
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Augusto T Caraceni, MD
• Phone: +390223902792
• Email: augusto.caraceni[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As above.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Other:
• Palliative 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)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient reported experience	patient satisfaction with care, measured with the FAMCARE-P13	through study completion, up to 6 months
Secondary	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
Secondary	caregiver experience of care	Family Care Satisfaction scale (FAMCARE)	through study completion, up to 6 months
Secondary	Activation of a Palliative Care service	Number of regular outpatient Palliative Care visits	through study completion, up to 6 months
Secondary	Multidisciplinary team visits	Number of multidisciplinary team visits (Oncology and Palliative Care)	through study completion, up to 6 months
Secondary	Hospitalization	Number of hospitalizations	through study completion, up to 6 months
Secondary	Emergency department accesses	Number of accesses in Emergency departement	through study completion, up to 6 months