Non-small Cell Lung CancerPhase 3NCT02988635
Early Palliative Care on Quality of Life of Advanced Cancer Patients
A Phase 3 study testing Early Palliative Care in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Azienda Ospedaliero-Universitaria di Parma.
Trial summary
This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Cancer
- What is being tested?
- Early Palliative Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 3
- 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
- Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.
Who cannot join
- Patients already receiving care from the PC service or pretreated with chemotherapy ± biological
About this study
Official title: Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.
Read the detailed description
The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.
Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.
Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.
- Being tested
- Early Palliative Care
- Keywords
- Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Palliative CareOther
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Early Palliative Care | Experimental | Subjects receive standard of care with early palliative care. Receives: Other: Early Palliative Care |
| Standard of Care | No intervention | Subjects receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
compare change in QOL from baseline to 12 weeks between study arms
Measured: Change from baseline to 12 weeks
Secondary outcomes (4)
Survival
Measured: from date of randomization until date of death or for a minimum of six months
Resource utilization at the end of life (EOL): chemotherapy utilization
percentage of patients who died, that in the 30 days preceding the death received chemotherapy
Measured: From date of randomization until death or for a minimum of six months after enrollment
Resource utilization at the end of life (EOL): hospital admissions
percentage of patients who died, that in the 30 days preceding the death were admitted to hospital
Measured: From date of randomization until death or for a minimum of six months after enrollment
Resource utilization at the end of life (EOL): emergency room admissions
percentage of patients who died, that in the 30 days preceding the death went to the emergency room
Measured: From date of randomization until death or for a minimum of six months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Emilia-Romagna
- Responsible party
- Principal investigator, Vittorio Franciosi, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- VITTORIO FRANCIOSI, M.D., Principal investigator, UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988635
- Sponsor's protocol ID
- RERSCE35E13
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02988635
- Acronym / sponsor ID
- RERSCE35E13
- Keywords
- Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Collaborators
- Regione Emilia-Romagna
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Dec 2016 (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.
This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.
Detailed description
The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.
Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.
Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Palliative Care | Experimental | Other: Early Palliative CareSubjects receive standard of care with early palliative care. |
| Standard of Care | No intervention | –Subjects receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.
Key exclusion criteria (1 listed)
- Patients already receiving care from the PC service or pretreated with chemotherapy ± biological
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 |
|---|---|---|
| Early Palliative CareSubjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment. | Other | Early Palliative Care |
Primary outcome
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
Time frame: Change from baseline to 12 weeks
compare change in QOL from baseline to 12 weeks between study arms
4 secondary outcomes
Survival
Time frame: from date of randomization until date of death or for a minimum of six months
Resource utilization at the end of life (EOL): chemotherapy utilization
Time frame: From date of randomization until death or for a minimum of six months after enrollment
Resource utilization at the end of life (EOL): hospital admissions
Time frame: From date of randomization until death or for a minimum of six months after enrollment
Resource utilization at the end of life (EOL): emergency room admissions
Time frame: From date of randomization until death or for a minimum of six months after enrollment
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 9 Dec 2016.
- 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.
VITTORIO FRANCIOSI, M.D. principal investigator
UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early Palliative Care in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Azienda Ospedaliero-Universitaria di Parma.
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 1 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure) (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2016.