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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02078700
Enrollment
40
Registered
2014-03-05
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Lung Cancer, Mesothelioma, Pancreas Cancer

Keywords

cancer, early palliative care, feasibility

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).

Interventions

OTHERThe 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.

Sponsors

Azienda USL Reggio Emilia - IRCCS
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of cancer patients that accept and attend the early palliative care programmeup to 30 days after the diagnosis of cancerpercentage 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

MeasureTime frameDescription
percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologistsup to 30 days after the diagnosis of cancerpercentage of newly diagnosed eligible cancer patients that receive the proposal of the itegrated early palliative care programme

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026