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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078700
• Other study ID #: CE148/2012
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2014
• Last updated: July 6, 2017
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Lung Cancer
• Mesothelioma
• Neoplasm Metastasis
• Pancreas Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Arcispedale S.Maria Nuova	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of cancer patients that accept and attend the early palliative care programme	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	up to 30 days after the diagnosis of cancer
Secondary	percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists	percentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme	up to 30 days after the diagnosis of cancer