Clinical trial NCT04936568: Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Keywords: early palliative care
referral
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient reported experience
timeFrame: through study completion, up to 6 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: through study completion, up to 6 months
measure: caregiver experience of care
timeFrame: through study completion, up to 6 months
measure: Activation of a Palliative Care service
timeFrame: through study completion, up to 6 months
measure: Multidisciplinary team visits
timeFrame: through study completion, up to 6 months
measure: Hospitalization
timeFrame: through study completion, up to 6 months
measure: Emergency department accesses
timeFrame: through study completion, up to 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Augusto T Caraceni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunelli C, Zecca E, Pigni A, Bracchi P, Caputo M, Lo Dico S, Fusetti V, Tallarita A, Bergamini C, Brambilla M, Raimondi A, Niger M, Provenzano S, Sepe P, Alfieri S, Tine G, De Braud F, Caraceni AT. Outpatient palliative care referral system (PCRS) for patients with advanced cancer: an impact evaluation protocol. BMJ Open. 2022 Oct 28;12(10):e059410. doi: 10.1136/bmjopen-2021-059410.