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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02078700
First Posted: March 5, 2014
Last Update Posted: July 7, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS
  Purpose
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).

Condition Intervention Phase
Lung Cancer Mesothelioma Pancreas Cancer Gastric Cancer Other: The early palliative care programme Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

Resource links provided by NLM:


Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • percentage of cancer patients that accept and attend the early palliative care programme [ Time Frame: up to 30 days after the diagnosis of cancer ]
    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 [ Time Frame: up to 30 days after the diagnosis of cancer ]
    percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme


Enrollment: 40
Study Start Date: July 2013
Study Completion Date: December 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT02078700


Locations
Italy
IRCCS Arcispedale S.Maria Nuova
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
  More Information

Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02078700     History of Changes
Other Study ID Numbers: CE148/2012
First Submitted: March 1, 2014
First Posted: March 5, 2014
Last Update Posted: July 7, 2017
Last Verified: January 2015

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
cancer
early palliative care
feasibility

Additional relevant MeSH terms:
Stomach Neoplasms
Mesothelioma
Neoplasm Metastasis
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases


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