Early Palliative Care and Hematological Cancer Patients (EPC-EMA1)
Primary Purpose
Hematologic Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
early palliative care
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Neoplasms focused on measuring palliative care, cancer, hematologic malignancies
Eligibility Criteria
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
Sites / Locations
- Arcispedale santa maria nuova-viale risorgimento 80Recruiting
- Viale Risorgimento 80Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard care
early palliative care
Arm Description
Patients in this arm will receive standard hematological care and palliative care on demand
early palliative care: patients in this arm will receive integrated palliative care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
incidence of anxiety and depression between patients enrolled
assessed by
- Hospital Anxiety and Depression Scale,range 0-42, higher value means worse outcomes
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
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
Full Information
NCT ID
NCT03743480
First Posted
November 5, 2018
Last Updated
January 14, 2020
Sponsor
Arcispedale Santa Maria Nuova-IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT03743480
Brief Title
Early Palliative Care and Hematological Cancer Patients
Acronym
EPC-EMA1
Official Title
Early Palliative Care and Hematological Cancer Patients: a Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arcispedale Santa Maria Nuova-IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
palliative care, cancer, hematologic malignancies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
centralized randomization
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Patients in this arm will receive standard hematological care and palliative care on demand
Arm Title
early palliative care
Arm Type
Experimental
Arm Description
early palliative care: patients in this arm will receive integrated palliative care
Intervention Type
Other
Intervention Name(s)
early palliative care
Intervention Description
experimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment
Primary Outcome Measure Information:
Title
Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment
Description
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
Time Frame
3 months after the enrollment
Secondary Outcome Measure Information:
Title
Quality of life of patients assessed by Palliative Care Outcomes Scale
Description
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
Time Frame
At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Title
quality of life of patients assessed by symptoms control 'measurement
Description
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
Time Frame
At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Title
incidence of anxiety and depression between patients enrolled
Description
assessed by
- Hospital Anxiety and Depression Scale,range 0-42, higher value means worse outcomes
Time Frame
At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Title
Performance status changing during the program
Description
during the follows 6 months will be assessed by Eastern Cooperative Oncology Group. It measures performance status, range 0-5, higher value worse outcomes
Time Frame
At the time of the randomization, after 4 weeks from the randomization and then every 4 weeks for 6 months
Title
Qualitative evaluation by patients/caregivers on palliative care program
Description
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
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
silvia tanzi, md
Phone
+390522295325
Email
silvia.tanzi@ausl.re.it
First Name & Middle Initial & Last Name or Official Title & Degree
elena turola, data manager
Phone
+390522295369
Email
elena.turola@ausl.re.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Tanzi, MD
Organizational Affiliation
Arcispedale Santa Maria Nuova-IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arcispedale santa maria nuova-viale risorgimento 80
City
Reggio Emilia
State/Province
Emilia Romagna
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
silvia tanzi, MD
Phone
+393476274230
Facility Name
Viale Risorgimento 80
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32321483
Citation
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.
Results Reference
derived
Learn more about this trial
Early Palliative Care and Hematological Cancer Patients
We'll reach out to this number within 24 hrs