Pancreatic NeoplasmNCT01996540

The Role of Early Systematic Best Palliative Care Versus on Request Palliative Care Consultation During Standard Oncologic Treatment for Patients With Advanced Gastric or Pancreatic Cancers: a Randomized, Controlled, Multicenter Trial.

A study testing Interventional arm: Early best palliative care in people with Pancreatic Neoplasm and Gastric Neoplasm, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 30 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Title: The role of early systematic best palliative care versus on request palliative care consultation during standard oncologic treatment for patients with advanced gastric or pancreatic cancers: a randomized, controlled, multicenter trial. Description of Study Treatment: 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Neoplasm, Gastric Neoplasm
What is being tested?: Interventional arm: Early best palliative care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 394 participants
Where: 30 sitesItaly
Study dates: Aug 2012to Nov 2018
Phase: Interventional
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

diagnosis of inoperable locally advanced and/or metastatic gastric or pancreatic cancers within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
patients eligible for chemotherapy and/or new target drugs treatments for metastatic or advanced disease;
ECOG PS 0-2 (Appendix A);
life expectancy >2 months;
both sex;
age ≥18 years;

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all ethnic background;
subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
written informed consent (Appendix B);
palliative care visit must be performed by a dedicated physician/team different from the medical oncology group.

Who cannot join

patients already receiving care from the palliative care service;
prior chemotherapy and/or new target drugs treatments for metastatic or advanced disease.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Italy30 sites

S. Donato, Arezzo
Arezzo
Centro di Riferimento Oncologico CRO
Aviano
Ospedale degli Infermi,
Biella
Ospedale Businco, Cagliari
Cagliari
Policlinico Universitario, Cagliari
Cagliari
ASL AL, Casale Monferrato
Casale Monferrato
Irst-Cesena
Cesena
Sant'Anna
Como
PO M.Santo, Cosenza
Cosenza
Istituti Ospitalieri, Cremona
Cremona
Sant'Anna, Ferrara
Ferrara
S.Giovanni Di Dio, Firenze
Florence
S.Maria Annunziata,
Florence
E.O. Galliera
Genova
U.O Oncologia medica
Lugo, RA, 48022
Palliative Care Clinic IRCCS IRST
Meldola, FC, 47014
Aulss 12,
Mestre
Istituto Nazionale Tumori, Milano
Milan
Ospedale Sacco, Milano
Milan
S.PAOLO
Milan
IOV
Padova
San Matteo
Pavia
Guglielmo da Saliceto
Piacenza
Arcispedale S. Maria Nuova
Reggio Emilia
Fatebenefratelli,
Roma
SS Trinità,
Sora - Frosinone
Gradinego
Torino
AOP 9, Trapani
Trapani
S. Maria Gruccia, Valdarno
Valdarno
AULSS 12, Venezia
Venezia

Other trials in Italy

About this study

Description of Study Treatment:

Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients. The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs. Palliative care doctor must have the possibility to decide about organizational arrangements. He has to perform the palliative care visit according to Temel indications.
Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.

Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.

Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.

Read the detailed description

Short Title/Acronym: Early palliative care

Protocol Code: IRST 100.08

Study Design: randomized, controlled, multicenter trial

Study Duration: 2 years

Number of Subjects: 240

Description of Study Treatment:

Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients. The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs. Palliative care doctor must have the possibility to decide about organizational arrangements. He has to perform the palliative care visit according to Temel indications.
Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.

Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.

Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.

Primary Objective:

To assess the effects on quality of life and clinical symptoms of introducing early systematic palliative care versus on request palliative care consultation during standard oncological care on quality of life.

Secondary Objectives:

To assess the impact of early palliative care on symptom burden and mood.
To assess the impact of families satisfaction about care.
To compare the use of health services, including anticancer therapy, medication prescriptions, referral to hospice, hospital admissions, emergency department visits, and the location of death between study arms.
To compare overall survival.

Statistical Methodology:

Primary endpoint is the change in the score from T0 to T1 on the Trial Outcome Index (TOI), which is the sum of the scores of specific subscale FACT-Ga or FACT-Hep concerning physical symptoms, and physical and functional well being.

Secondary endpoints are the change in the percentage of patients with anxiety and/or depression form T0 to T1 on the Mood questionnaire; the impact of families satisfaction about care; the use of health services, including anticancer therapy, medication prescriptions, referral to hospice, hospital admissions, emergency department visits, and the location of death between study arms; the overall survival.

For each type of cancer (gastric or pancreatic), we estimate that with 120 patients the study would have 80% power to detect a significant between-group difference in the change in the TOI score from T0 to T1, with a medium effect size of 0.5 standard deviation. A total of 240 patients will be enrolled.

Conditions: Pancreatic Neoplasm, Gastric Neoplasm
Being tested: Interventional arm: Early best palliative care
Keywords: gastric neoplasm, pancreatic neoplasm, advanced, palliative care
Medical subject headings: Pancreatic Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interventional arm: Early best palliative careOther
Also called Early best palliative care
Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death.

Study groups in NCT01996540
Study group	Role	What they receive
Interventional arm	Experimental	Interventional arm Receives: Other: Interventional arm: Early best palliative care
Standard arm	No intervention	Standard arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life (QoL)
It is the change in the score from T0 (day of enrollment) to T1 (12±3 weeks) on the Trial Outcome Index (TOI) [which is the sum of the scores of specific subscale FACT-Ga or FACT-Hep Functional Assessment of Cancer Therapy-Gastric cancer (FACT-Ga) and Functional Assessment of Cancer Therapy-Hepatobiliary cancers (FACT-Hep) scales, concerning physical symptoms, physical and functional well being].
Measured: 24 months

Secondary outcomes (3)

Hospital Anxiety and Depression Scale (HADS)
Mood will be assessed with the use of Hospital Anxiety and Depression Scale (HADS), which is 14-item instrument composed of two subscales and screens for symptoms of anxiety and depression.
Measured: 24 months
Impact of families satisfaction
The impact of families satisfaction about care will be evaluated by an Italian version of FAMCARE questionnaire.
Measured: 24 months
Overall survival (OS)
It is the time from the date of randomization to the date of death due to any cause.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Nov 2018

First posted27 Nov 2013 (estimated)
Study startAug 2012
Primary completion2 Nov 2017
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pancreatic NeoplasmStudies 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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 394 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996540
Sponsor's protocol ID: IRST100.08
Status last verified: Nov 2018
First submitted: 22 Nov 2013
Last updated: 13 Nov 2018
Results posted: No
Data monitoring committee: No

Publications

Scarpi E, Dall'Agata M, Zagonel V, Gamucci T, Berte R, Sansoni E, Amaducci E, Broglia CM, Alquati S, Garetto F, Schiavon S, Quadrini S, Orlandi E, Casadei Gardini A, Ruscelli S, Ferrari D, Pino MS, Bortolussi R, Negri F, Stragliotto S, Narducci F, Valgiusti M, Farolfi A, Nanni O, Rossi R, Maltoni M; Early Palliative Care Italian Study Group (EPCISG). Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. Support Care Cancer. 2019 Jul;27(7):2425-2434. doi: 10.1007/s00520-018-4517-2. Epub 2018 Oct 24.
PubMed 30357555
Maltoni M, Scarpi E, Dall'Agata M, Schiavon S, Biasini C, Codeca C, Broglia CM, Sansoni E, Bortolussi R, Garetto F, Fioretto L, Cattaneo MT, Giacobino A, Luzzani M, Luchena G, Alquati S, Quadrini S, Zagonel V, Cavanna L, Ferrari D, Pedrazzoli P, Frassineti GL, Galiano A, Casadei Gardini A, Monti M, Nanni O; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life. Eur J Cancer. 2016 Dec;69:110-118. doi: 10.1016/j.ejca.2016.10.004. Epub 2016 Nov 4.
PubMed 27821313
Maltoni M, Scarpi E, Dall'Agata M, Zagonel V, Berte R, Ferrari D, Broglia CM, Bortolussi R, Trentin L, Valgiusti M, Pini S, Farolfi A, Casadei Gardini A, Nanni O, Amadori D; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial. Eur J Cancer. 2016 Sep;65:61-8. doi: 10.1016/j.ejca.2016.06.007. Epub 2016 Jul 26.
PubMed 27472648

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Early Systematic Best Palliative Care Versus on Request Palliative Care Consultation During Standard Oncologic Treatment for Patients With Advanced Gastric or Pancreatic Cancers: a Randomized, Controlled, Multicenter Trial.
ClinicalTrials.gov ID: NCT01996540
Acronym / sponsor ID: IRST100.08
Conditions: Pancreatic Neoplasm, Gastric Neoplasm
Keywords: gastric neoplasm, pancreatic neoplasm, advanced, palliative care
Study type: Interventional
Recruitment status: Completed
Enrolment: 394 participants (actual)
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
Study start: Aug 2012 (actual)
Primary completion: 2 Nov 2017 (actual)
Study completion: Nov 2018 (actual)
First posted: 27 Nov 2013 (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.

Description of Study Treatment:

Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients. The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs. Palliative care doctor must have the possibility to decide about organizational arrangements. He has to perform the palliative care visit according to Temel indications.
Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.

Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.

Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.

Detailed description

Short Title/Acronym: Early palliative care

Protocol Code: IRST 100.08

Study Design: randomized, controlled, multicenter trial

Study Duration: 2 years

Number of Subjects: 240

Description of Study Treatment:

Interventional arm Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death. Patients assigned to this experimental arm will be evaluated if the total of palliative care visits between T0 (day of enrollment) and T1 (12±3 weeks) is ≥3. Palliative care visits and intervention has to be oriented by the General guidelines for palliative care: specific attention will be paid to assessing physical and psychosocial symptoms, establishing goals of care, assisting decision making regarding treatment, and coordinating care on the basis of the individual needs of the patients. The doctor expert in palliative care, with regular visits in the experimental arm, must be a physician dedicated full time to palliative care, that can directly prescribe drugs and other interventions, and with a particular attention to physical, psychological, and spiritual needs. Palliative care doctor must have the possibility to decide about organizational arrangements. He has to perform the palliative care visit according to Temel indications.
Standard arm Patients will receive standard oncologic care and will be assigned to on request palliative care consultation. They will be not scheduled to meet with the palliative care service unless a meeting will be requested by the patients, the family, or the oncologist. After the time of evaluation (T1) patients will be followed by the palliative care services as needed.

Patient completes QoL (Quality of Life) and mood questionnaires at baseline and at 12 weeks ± 3.

Patients will receive standard antineoplastic treatment in both arms of the study according to best clinical practice in each participating centre.

Primary Objective:

Secondary Objectives:

To assess the impact of early palliative care on symptom burden and mood.
To assess the impact of families satisfaction about care.
To compare the use of health services, including anticancer therapy, medication prescriptions, referral to hospice, hospital admissions, emergency department visits, and the location of death between study arms.
To compare overall survival.

Statistical Methodology:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Interventional arm	Experimental	Other: Interventional arm: Early best palliative careInterventional arm
Standard arm	No intervention	–Standard arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

diagnosis of inoperable locally advanced and/or metastatic gastric or pancreatic cancers within the previous eight weeks, any T, any N, M+ or T4 inoperable (neoadjuvant excluded);
patients eligible for chemotherapy and/or new target drugs treatments for metastatic or advanced disease;
ECOG PS 0-2 (Appendix A);
life expectancy >2 months;
both sex;

Key exclusion criteria (2 listed)

patients already receiving care from the palliative care service;
prior chemotherapy and/or new target drugs treatments for metastatic or advanced disease.

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
Interventional arm: Early best palliative careAlso: Early best palliative carePatients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death.	Other	Interventional arm

Primary outcome

Quality of Life (QoL)
Time frame: 24 months
It is the change in the score from T0 (day of enrollment) to T1 (12±3 weeks) on the Trial Outcome Index (TOI) [which is the sum of the scores of specific subscale FACT-Ga or FACT-Hep Functional Assessment of Cancer Therapy-Gastric cancer (FACT-Ga) and Functional Assessment of Cancer Therapy-Hepatobiliary cancers (FACT-Hep) scales, concerning physical symptoms, physical and functional well being].

3 secondary outcomes

Hospital Anxiety and Depression Scale (HADS)
Time frame: 24 months
Impact of families satisfaction
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months

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 13 Nov 2018.
Derived from this study: PubMed 30357555Scarpi E, Dall'Agata M, Zagonel V, Gamucci T, Berte R, Sansoni E, Amaducci E, Broglia CM, Alquati S, Garetto F, Schiavon S, Quadrini S, Orlandi E, Casadei Gardini A, Ruscelli S, Ferrari D, Pino MS, Bortolussi R, Negri F, Stragliotto S, Narducci F, Valgiusti M, Farolfi A, Nanni O, Rossi R, Maltoni M; Early Palliative Care Italian Study Group (EPCISG). Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. Support Care Cancer. 2019 Jul;27(7):2425-2434. doi: 10.1007/s00520-018-4517-2. Epub 2018 Oct 24.
Derived from this study: PubMed 27821313Maltoni M, Scarpi E, Dall'Agata M, Schiavon S, Biasini C, Codeca C, Broglia CM, Sansoni E, Bortolussi R, Garetto F, Fioretto L, Cattaneo MT, Giacobino A, Luzzani M, Luchena G, Alquati S, Quadrini S, Zagonel V, Cavanna L, Ferrari D, Pedrazzoli P, Frassineti GL, Galiano A, Casadei Gardini A, Monti M, Nanni O; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life. Eur J Cancer. 2016 Dec;69:110-118. doi: 10.1016/j.ejca.2016.10.004. Epub 2016 Nov 4.
Derived from this study: PubMed 27472648Maltoni M, Scarpi E, Dall'Agata M, Zagonel V, Berte R, Ferrari D, Broglia CM, Bortolussi R, Trentin L, Valgiusti M, Pini S, Farolfi A, Casadei Gardini A, Nanni O, Amadori D; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial. Eur J Cancer. 2016 Sep;65:61-8. doi: 10.1016/j.ejca.2016.06.007. Epub 2016 Jul 26.

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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.

Marco Maltoni, MD principal investigator

IRST IRCCS, Meldola

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 2 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites 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.

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?

Quality of Life (QoL) (time frame: 24 months). 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 NCT01996540, which also lists 3 linked publications.

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 13 Nov 2018.