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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Recruiting
CT.gov ID
NCT04936568
Collaborator
(none)
300
1
2
25.6
11.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Palliative Care Referral System - PCRS
N/A

Detailed Description

As above.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Health Services Research
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.
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control

standard oncology care

Experimental: intervention

standardized referral to outpatient palliative care by oncologists

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)

Outcome Measures

Primary Outcome Measures

  1. patient reported experience [through study completion, up to 6 months]

    patient satisfaction with care, measured with the FAMCARE-P13

Secondary Outcome Measures

  1. 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)

  2. caregiver experience of care [through study completion, up to 6 months]

    Family Care Satisfaction scale (FAMCARE)

  3. Activation of a Palliative Care service [through study completion, up to 6 months]

    Number of regular outpatient Palliative Care visits

  4. Multidisciplinary team visits [through study completion, up to 6 months]

    Number of multidisciplinary team visits (Oncology and Palliative Care)

  5. Hospitalization [through study completion, up to 6 months]

    Number of hospitalizations

  6. Emergency department accesses [through study completion, up to 6 months]

    Number of accesses in Emergency departement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy 20133

Sponsors and Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Augusto T Caraceni, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Augusto Caraceni, director of Palliative Care Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT04936568
Other Study ID Numbers:
  • 201/19
First Posted:
Jun 23, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Augusto Caraceni, director of Palliative Care Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Results

No Results Posted as of Aug 4, 2021