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


2013-07


2014-04


2014-12


40

Study Overview

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

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).

N/A

  • Lung Cancer
  • Mesothelioma
  • Pancreas Cancer
  • Gastric Cancer
  • OTHER: The early palliative care programme
  • CE148/2012

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2014-03-01  

N/A  

2025-06-20  

2014-03-03  

N/A  

2025-06-25  

2014-03-05  

N/A  

2015-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: early palliative care programme

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

OTHER: The early palliative care programme

  • 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 Car
Primary Outcome MeasuresMeasure DescriptionTime Frame
percentage of cancer patients that accept and attend the early palliative care programmepercentage 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 Unitup to 30 days after the diagnosis of cancer
Secondary Outcome MeasuresMeasure DescriptionTime Frame
percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologistspercentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programmeup to 30 days after the diagnosis of cancer

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.