Early Palliative Care and Hematological Cancer Patients (EPC-EMA1)

Early Palliative Care and Hematological Cancer Patients: a Phase II Study

The aim of the study is to pilot and evaluate a new integration model between a Specialised Palliative Care (SPC) intervention and standard hematological care in an Italian hospital. This is a feasibility mix-methods study, where a sample of advanced hematological patients are randomised to receive integrated hematological care and a SPC intervention or standard hematological care throughout the course of the predictive last active treatment.

Study Overview

• Status: Unknown
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Other: early palliative care

Detailed Description

The most recent World Health Organization (WHO) definition of palliative care advocates that palliative care principles "…should be applied as early as possible in the course of any chronic, ultimately fatal illness". The difference with the previous WHO vision was substantial, as the earlier definition recommended Palliative Care to patients not responsive to curative therapy, limiting its role to the last period of life.

Evidence about the effectiveness of an early integration of palliative care has begun to emerge in the last years, primarily for cancer patients. The results of experimental studies, showed the effectiveness of early integration of palliative in the management of advanced illness, in improving quality of life, reducing consumption of resources, and possibly increasing survival. These data were also confirmed in Italy.

Hematological advanced patients suffer from a very high symptoms burden, psychological, spiritual, social and physical symptoms. They are very similar to oncological advanced patients. Hematologic patients during the last 30 days of their life are more frequently admitted in Hospital setting, emergency departments and high care ward than oncological patients, they received more aggressive treatments and more chemotherapy or biologic active treatments than oncologic patients.

Looking to WHO's palliative care definition and hematologic patients' symptoms burden it's simple to imagine that an early access to palliative care service could be the answer, as it was for advanced oncologic patients. The rational of the new vision lied on the recognition that palliative care had the potential to improve quality of life of patients and their family members during the whole trajectory of an incurable disease, through an effective management of psychological and physical symptoms, appropriate relationships, effective communication and support in decision-making.

In addition, even if WHO definition is referred to incurable patients, recent experience on Palliative care and Hematology is also about potentially curative patients.

Nonetheless, access to palliative care in hematologic patients care results totally absent or confined in the last days of life.There is a resistance by hematologic specialists to address patients to a palliative care service because of the possible misunderstanding between active treatment and palliative care assistance, identified from many professionals as terminal care A call to a new model of integration between palliative care and hematologic service is strong; for some authors just from the beginning of an advanced disease and for other authors modelled on the different patients' needs.

The aim of the study is to pilot a new model of integration for advanced hematological cancer between hematology and palliative care. Eligible patients will be at their last active treatment (chemotherapy or immunotherapy) as decided by hematologists.

The primary aim is to evaluate the feasibility, acceptability and efficacy of this novel intervention.

The evaluation procedure will be evaluated for feasibility and applicability To the investigators knowledge this is the first trial on an integrative model between palliative care and hematology for an advanced hematological population.

Primary aim

To evaluate the feasibility of integrated versus standard involvement of palliative team for hematological advanced patients.

Secondary aims to evaluate the efficacy of this new model on Quality of Life (QoL) until 6 months after the enrollment.

to evaluate the impact of the intervention on care pathways (number of chemotherapies in the last 30 days, number of exams, length of stay in Hospital or Hospice, access to emergency department, setting of death and so on) to evaluate the acceptability of the intervention by patients, professionals and caregivers.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: silvia tanzi, md; Phone Number: +390522295325; Email: silvia.tanzi@ausl.re.it
• Study Contact Backup: Name: elena turola, data manager; Phone Number: +390522295369; Email: elena.turola@ausl.re.it

Study Locations

• Italy
  • Reggio Emilia, Italy
    • Recruiting
    • Viale Risorgimento 80
  • Emilia Romagna
    • Reggio Emilia, Emilia Romagna, Italy, 42123
      • Recruiting
      • Arcispedale santa maria nuova-viale risorgimento 80
      • Contact: silvia tanzi, MD; Phone Number: +393476274230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed incurable hematological tumor;
• Estimated prognosis by the hematologist more than 1 month at least;
• Predictive last active treatment (chemotherapy or immunotherapy) as established by hematological team;
• 18 years old;
• Eastern Cooperative Oncology Group ≤ 3;
• Ability to read and respond to questions in Italian;
• Consent to the study

Exclusion Criteria:

• Existence of other co morbid disease which in the opinion of the investigator prohibits participation in the protocol;
• Caregiver's absence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care; Patients in this arm will receive standard hematological care and palliative care on demand
Experimental: early palliative care; early palliative care: patients in this arm will receive integrated palliative care	Other: early palliative care; experimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment	the investigators consecutively register all eligible patients (and reasons for ineligibility) both from Hematological department, patients who were asked to participate to the study (and reasons for not), patients who accepted to participate (and reasons for not). The feasibility will be achieved if >50% of patients remain in the program in the next 3 months from the enrollment	3 months after the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients assessed by Palliative Care Outcomes Scale	The efficacy on QoL during the follows 6 months will be assessed by Palliative Care Outcomes Scale. range 0-40,higher value means worse outcome	At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
quality of life of patients assessed by symptoms control 'measurement	1. The efficacy on QoL during the follows 6 months will be assessed by Edmonton Symptom Assessment System. Range 0-100. Higher value means worse outcomes	At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
incidence of anxiety and depression between patients enrolled	assessed by - Hospital Anxiety and Depression Scale,range 0-42, higher value means worse outcomes	At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Performance status changing during the program	during the follows 6 months will be assessed by Eastern Cooperative Oncology Group. It measures performance status, range 0-5, higher value worse outcomes	At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Qualitative evaluation by patients/caregivers on palliative care program	individual semi-structured interviews exploring the experience of the different 'actors' of the intervention, i.e. the receivers (patients and family members) and professionals. Semistructured interviews are in deep interviews and they are not linked to a scale	After 12 weeks from the randomization for patients or caregivers. Investigators establish as necessary that patients have attended 3 palliative care visits. Professionals will be interview at the end of the enrolment

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Investigators: Principal Investigator: Silvia Tanzi, MD, Arcispedale Santa Maria Nuova-IRCCS

Publications and helpful links

General Publications

• Tanzi S, Luminari S, Cavuto S, Turola E, Ghirotto L, Costantini M. Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial. BMC Palliat Care. 2020 Apr 22;19(1):53. doi: 10.1186/s12904-020-00561-w.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: palliative care; cancer; hematologic malignancies
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2018/0056350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No