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Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

Primary Purpose

Lung Cancer, Mesothelioma, Pancreas Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
The early palliative care programme
Sponsored by
Arcispedale Santa Maria Nuova-IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring cancer, early palliative care, feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients within 8 weeks of cancer diagnosis confirmed by histology or cytology
  • lung cancer (NSCLC or SCLC) stage IIIb-IV OR mesothelioma stage III-IV OR pancreas cancer stage IV, OR gastric cancer stage IIIb-IV
  • age more than 18 years
  • performance status (ECOG) ≤ 2;
  • ability to read, understand and fill-in the questionnaires
  • written informed consent to the study

Exclusion Criteria:

  • any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months

Sites / Locations

  • IRCCS Arcispedale S.Maria Nuova

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

early palliative care programme

Arm Description

Patients will be proposed to be followed by the Palliative Care Team

Outcomes

Primary Outcome Measures

percentage of cancer patients that accept and attend the early palliative care programme
percentage of eligible cancer patients that accept the proposal of the intervention (the early palliative care programme) and that, by 30 days after the diagnosis, effectively start to be followed by the Palliative Care Unit

Secondary Outcome Measures

percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists
percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme

Full Information

First Posted
March 1, 2014
Last Updated
July 6, 2017
Sponsor
Arcispedale Santa Maria Nuova-IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT02078700
Brief Title
Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
Official Title
Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcispedale Santa Maria Nuova-IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. Feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. The study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach (stage IIIb-IV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Mesothelioma, Pancreas Cancer, Gastric Cancer
Keywords
cancer, early palliative care, feasibility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early palliative care programme
Arm Type
Experimental
Arm Description
Patients will be proposed to be followed by the Palliative Care Team
Intervention Type
Other
Intervention Name(s)
The early palliative care programme
Intervention Description
The intervention consists of an early integration of a palliative care programme with the standard care performed by the oncologists-pneumologists that are following the cancer patients. The intervention will be delivered by the specialised Palliative Care Unit (PCU) of the hospital. Each patient meets the professionals of the PCU by 30 days by cancer diagnosis and at least monthly thereafter in the outpatint settings.
Primary Outcome Measure Information:
Title
percentage of cancer patients that accept and attend the early palliative care programme
Description
percentage of eligible cancer patients that accept the proposal of the intervention (the early palliative care programme) and that, by 30 days after the diagnosis, effectively start to be followed by the Palliative Care Unit
Time Frame
up to 30 days after the diagnosis of cancer
Secondary Outcome Measure Information:
Title
percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists
Description
percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme
Time Frame
up to 30 days after the diagnosis of cancer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients within 8 weeks of cancer diagnosis confirmed by histology or cytology lung cancer (NSCLC or SCLC) stage IIIb-IV OR mesothelioma stage III-IV OR pancreas cancer stage IV, OR gastric cancer stage IIIb-IV age more than 18 years performance status (ECOG) ≤ 2; ability to read, understand and fill-in the questionnaires written informed consent to the study Exclusion Criteria: any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months
Facility Information:
Facility Name
IRCCS Arcispedale S.Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28952881
Citation
Costantini M, Apolone G, Tanzi S, Falco F, Rondini E, Guberti M, Fanello S, Cavuto S, Savoldi L, Piro R, Mecugni D, Di Leo S. Is early integration of palliative care feasible and acceptable for advanced respiratory and gastrointestinal cancer patients? A phase 2 mixed-methods study. Palliat Med. 2018 Jan;32(1):46-58. doi: 10.1177/0269216317731571. Epub 2017 Sep 27.
Results Reference
derived

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Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

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