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

Phase 2

Completed

• Conditions: Lung Cancer; Gastric Cancer; Mesothelioma; Pancreas Cancer
• Interventions: Other: The early palliative care programme

• Registration Number: NCT02078700
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
early palliative care programme	The early palliative care programme	Patients will be proposed to be followed by the Palliative Care Team

Primary Outcome Measures

Name	Time	Method
percentage of cancer patients that accept and attend the early palliative care programme	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

Name	Time	Method
percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists	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

Trial Locations

Locations (1)

IRCCS Arcispedale S.Maria Nuova; 🇮🇹 Reggio Emilia, Italy