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

Azienda USL Reggio Emilia - IRCCS

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Pancreas Cancer; Lung Cancer; Mesothelioma

Treatments: Other: The early palliative care programme

Study type: Interventional

Funder types: Other

Identifiers

NCT02078700

CE148/2012

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

early palliative care programme

Experimental group

Description:

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

Treatment:

Other: The early palliative care programme