Early Palliative Care and Hematological Cancer Patients

NCT03743480 | Terminated

• 1 other identifier: 2018/0056350
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematologic Neoplasms

Keywords

palliative care; cancer; hematologic malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life of patients assessed by Palliative Care Outcomes Scale

  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

  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

  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

  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

  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

Study Arms (2)

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

Other: early palliative care

Interventions

early palliative care OTHER

experimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment

early palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old;
• Eastern Cooperative Oncology Group ≤ 3;
• Ability to read and respond to questions in Italian;
• Consent to the study

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (2)

Arcispedale santa maria nuova-viale risorgimento 80

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Viale Risorgimento 80

Reggio Emilia, Italy

Location

Related Publications (1)

• 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.

  PMID: 32321483 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Silvia Tanzi, MD

  Azienda USL Reggio Emilia - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: centralized randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 16, 2018
• Study Start: November 21, 2018
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: June 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)