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Trial record 15 of 1317 for:    Hematologic neoplasm

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743480
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Silvia Tanzi, Arcispedale Santa Maria Nuova-IRCCS

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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Other: early palliative care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: centralized randomization
Primary Purpose: Supportive Care
Official Title: Early Palliative Care and Hematological Cancer Patients: a Phase II Study
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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

  3. 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 ]

    assessed by

    - Hospital Anxiety and Depression Scale,range 0-42, higher value means worse outcomes


  4. 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 ]
    during the follows 6 months will be assessed by Eastern Cooperative Oncology Group. It measures performance status, range 0-5, higher value worse outcomes

  5. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743480


Contacts
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Contact: silvia tanzi, md +390522295325 silvia.tanzi@ausl.re.it
Contact: elena turola, data manager +390522295369 elena.turola@ausl.re.it

Locations
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Italy
Arcispedale santa maria nuova-viale risorgimento 80 Recruiting
Reggio Emilia, Emilia Romagna, Italy, 42123
Contact: silvia tanzi, MD    +393476274230      
Viale Risorgimento 80 Recruiting
Reggio Emilia, Italy
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
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Principal Investigator: Silvia Tanzi, MD Arcispedale Santa Maria Nuova-IRCCS
  Study Documents (Full-Text)

Documents provided by Silvia Tanzi, Arcispedale Santa Maria Nuova-IRCCS:

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Responsible Party: Silvia Tanzi, Principal Investigator, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT03743480     History of Changes
Other Study ID Numbers: 2018/0056350
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Tanzi, Arcispedale Santa Maria Nuova-IRCCS:
palliative care
cancer
hematologic malignancies
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases