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

NCT ID: NCT02078700

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Lung Cancer Mesothelioma Pancreas Cancer Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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early palliative care programme

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

Group Type EXPERIMENTAL

The early palliative care programme

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Arcispedale S.Maria Nuova

Reggio Emilia, , Italy

Site Status

Countries

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Italy

References

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Costantini M, Apolone G, Tanzi S, Falco F, Rondini E, Guberti M, Fanello S, Cavuto S, Savoldi L, Piro R, Mecugni D, Di Leo S. Is early integration of palliative care feasible and acceptable for advanced respiratory and gastrointestinal cancer patients? A phase 2 mixed-methods study. Palliat Med. 2018 Jan;32(1):46-58. doi: 10.1177/0269216317731571. Epub 2017 Sep 27.

Reference Type DERIVED
PMID: 28952881 (View on PubMed)

Other Identifiers

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CE148/2012

Identifier Type: -

Identifier Source: org_study_id

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