- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02078700
Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
July 6, 2017 updated by: Arcispedale Santa Maria Nuova-IRCCS
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Reggio Emilia, Italy, 42123
- IRCCS Arcispedale S.Maria Nuova
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: early palliative care programme
Patients will be proposed to be followed by the Palliative Care Team
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of cancer patients that accept and attend the early palliative care programme
Time Frame: up to 30 days after the diagnosis of cancer
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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
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up to 30 days after the diagnosis of cancer
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists
Time Frame: 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
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up to 30 days after the diagnosis of cancer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 1, 2014
First Submitted That Met QC Criteria
March 3, 2014
First Posted (Estimate)
March 5, 2014
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neoplastic Processes
- Pancreatic Diseases
- Adenoma
- Neoplasms, Mesothelial
- Neoplasm Metastasis
- Pancreatic Neoplasms
- Mesothelioma
Other Study ID Numbers
- CE148/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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