Skip to main content
Clinical Trials/NCT02078700
NCT02078700
Completed
Phase 2

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

Azienda USL Reggio Emilia - IRCCS1 site in 1 country40 target enrollmentJuly 1, 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Azienda USL Reggio Emilia - IRCCS
Enrollment
40
Locations
1
Primary Endpoint
percentage of cancer patients that accept and attend the early palliative care programme
Status
Completed
Last Updated
10 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2013
End Date
December 1, 2014
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Azienda USL Reggio Emilia - IRCCS
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists(up to 30 days after the diagnosis of cancer)

Study Sites (1)

Loading locations...

Similar Trials