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Clinical Trials/NCT04936568
NCT04936568
Completed
N/A

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.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 site in 1 country380 target enrollmentJuly 14, 2021
ConditionsAdvanced Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Advanced Cancer
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrollment
380
Locations
1
Primary Endpoint
patient reported experience
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 14, 2021
End Date
September 18, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Responsible Party
Principal Investigator
Principal Investigator

Augusto Caraceni

director of Palliative Care Unit

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

Outcomes

Primary Outcomes

patient reported experience

Time Frame: through study completion, up to 6 months

patient satisfaction with care, measured with the FAMCARE-P13

Secondary Outcomes

  • Hospitalization(through study completion, up to 6 months)
  • caregiver experience of care(through study completion, up to 6 months)
  • Activation of a Palliative Care service(through study completion, up to 6 months)
  • Health related quality of life(through study completion, up to 6 months)
  • Multidisciplinary team visits(through study completion, up to 6 months)
  • Emergency department accesses(through study completion, up to 6 months)

Study Sites (1)

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