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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Arcispedale Santa Maria Nuova-IRCCS
Sponsor:
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT02078700
First received: March 1, 2014
Last updated: March 3, 2014
Last verified: February 2014
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme


Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078700

Contacts
Contact: Massimo Costantini, MD 0039 0522 29 5369 costantini.massimo@asmn.re.it
Contact: Silvia Tanzi, MD 0039 0522 29 5325 silvia.tanzi@asmn.re.it

Locations
Italy
IRCCS Arcispedale S.Maria Nuova Recruiting
Reggio Emilia, Italy, 42123
Contact: Massimo Costantini, MD    0039 0522 295369    costantini.massimo@asmn.re.it   
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
  More Information

No publications provided

Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02078700     History of Changes
Other Study ID Numbers: CE148/2012
Study First Received: March 1, 2014
Last Updated: March 3, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 29, 2014