Lung CancerPhase 2NCT02078700
Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
A Phase 2 study testing The early palliative care programme in people with Lung Cancer and Mesothelioma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mesothelioma, Pancreas Cancer
- What is being tested?
- The early palliative care programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Lung Cancer, Mesothelioma, Pancreas Cancer, Gastric Cancer
- Being tested
- The early palliative care programme
- Keywords
- cancer, early palliative care, feasibility
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Pancreatic Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The early palliative care programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| early palliative care programme | Experimental | Patients will be proposed to be followed by the Palliative Care Team Receives: Other: The early palliative care programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days after the diagnosis of cancer
Secondary outcomes (1)
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
Measured: up to 30 days after the diagnosis of cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078700
- Sponsor's protocol ID
- CE148/2012
- Status last verified
- Jan 2015
- First submitted
- 1 Mar 2014
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28952881
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
- ClinicalTrials.gov ID
- NCT02078700
- Acronym / sponsor ID
- CE148/2012
- Conditions
- Lung Cancer, Mesothelioma, Pancreas Cancer, Gastric Cancer
- Keywords
- cancer, early palliative care, feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early palliative care programme | Experimental | Other: The early palliative care programmePatients will be proposed to be followed by the Palliative Care Team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The early palliative care programmeThe 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. | Other | early palliative care programme |
Primary outcome
percentage of cancer patients that accept and attend the early palliative care programme
Time frame: 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 28952881Costantini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The early palliative care programme in people with Lung Cancer and Mesothelioma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of cancer patients that accept and attend the early palliative care programme (time frame: up to 30 days after the diagnosis of cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.