Hematologic NeoplasmsEPC-EMA1NCT03743480
Early Palliative Care and Hematological Cancer Patients
A study testing early palliative care in people with Hematologic Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- early palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesItaly
- Study dates
- 21 Nov 2018to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Existence of other co morbid disease which in the opinion of the investigator prohibits participation in the protocol;
- Caregiver's absence
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Arcispedale santa maria nuova-viale risorgimento 80
Reggio Emilia, Emilia-Romagna, 42123
Viale Risorgimento 80
Reggio Emilia
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematologic Neoplasms
- Being tested
- early palliative care
- Keywords
- palliative care, cancer, hematologic malignancies
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early palliative careOther
experimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | Patients in this arm will receive standard hematological care and palliative care on demand |
| early palliative care | Experimental | early palliative care: patients in this arm will receive integrated palliative care Receives: Other: early palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after the enrollment
Secondary outcomes (5)
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
Measured: 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
- 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start21 Nov 2018
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Silvia Tanzi, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743480
- Sponsor's protocol ID
- 2018/0056350
- Other IDs
- 2018
- Acronym
- EPC-EMA1
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32321483
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care and Hematological Cancer Patients: a Phase II Study
- ClinicalTrials.gov ID
- NCT03743480
- Acronym / sponsor ID
- EPC-EMA1 / 2018/0056350
- Conditions
- Hematologic Neoplasms
- Keywords
- palliative care, cancer, hematologic malignancies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –Patients in this arm will receive standard hematological care and palliative care on demand |
| early palliative care | Experimental | Other: early palliative careearly palliative care: patients in this arm will receive integrated palliative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- Existence of other co morbid disease which in the opinion of the investigator prohibits participation in the protocol;
- Caregiver's absence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early palliative careexperimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment | Other | early palliative care |
Primary outcome
Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment
Time frame: 3 months after the enrollment
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
5 secondary outcomes
Quality of life of patients assessed by Palliative Care Outcomes Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 32321483Tanzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Tanzi, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early palliative care in people with Hematologic Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the palliative care program assessed by percentage of patients attending palliative care visits after 3 months from the enrolment (time frame: 3 months after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03743480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.