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

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).

Tracking Information
First Received DateMarch 1, 2014
Last Changed DateJuly 30, 2015
Start DateJuly 2013
Actual Primary Completion DateApril 2014
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]

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]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Lung Cancer
  • Mesothelioma
  • Pancreas Cancer
  • Gastric Cancer
Intervention
  • Other: The early palliative care programme
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment40
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT02078700
Responsible Party,
SponsorArcispedale Santa Maria Nuova-IRCCS
Verification DateJanuary 2015
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