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.
1 other identifier
interventional
394
1 country
30
Brief 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.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.
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedNovember 13, 2018
November 1, 2018
5.3 years
November 22, 2013
November 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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) \[which is the sum of the scores of specific subscale FACT-Ga or FACT-Hep Functional Assessment of Cancer Therapy-Gastric cancer (FACT-Ga) and Functional Assessment of Cancer Therapy-Hepatobiliary cancers (FACT-Hep) scales, concerning physical symptoms, physical and functional well being\].
24 months
Secondary Outcomes (3)
Hospital Anxiety and Depression Scale (HADS)
24 months
Impact of families satisfaction
24 months
Overall survival (OS)
24 months
Study Arms (2)
Interventional arm
EXPERIMENTALInterventional arm
Standard arm
NO INTERVENTIONStandard arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- patients already receiving care from the palliative care service;
- prior chemotherapy and/or new target drugs treatments for metastatic or advanced disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Palliative Care Clinic IRCCS IRST
Meldola, FC, 47014, Italy
U.O Oncologia medica
Lugo, RA, 48022, Italy
S. Donato, Arezzo
Arezzo, Italy
Centro di Riferimento Oncologico CRO
Aviano, Italy
Ospedale degli Infermi,
Biella, Italy
Ospedale Businco, Cagliari
Cagliari, Italy
Policlinico Universitario, Cagliari
Cagliari, Italy
ASL AL, Casale Monferrato
Casale Monferrato, Italy
Irst-Cesena
Cesena, Italy
Sant'Anna
Como, Italy
PO M.Santo, Cosenza
Cosenza, Italy
Istituti Ospitalieri, Cremona
Cremona, Italy
Sant'Anna, Ferrara
Ferrara, Italy
S.Giovanni Di Dio, Firenze
Florence, Italy
S.Maria Annunziata,
Florence, Italy
E.O. Galliera
Genova, Italy
Aulss 12,
Mestre, Italy
Istituto Nazionale Tumori, Milano
Milan, Italy
Ospedale Sacco, Milano
Milan, Italy
S.PAOLO
Milan, Italy
IOV
Padua, Italy
San Matteo
Pavia, Italy
Guglielmo da Saliceto
Piacenza, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Fatebenefratelli,
Roma, Italy
SS Trinità,
Sora - Frosinone, Italy
Gradinego
Torino, Italy
AOP 9, Trapani
Trapani, Italy
S. Maria Gruccia, Valdarno
Valdarno, Italy
AULSS 12, Venezia
Venezia, Italy
Related Publications (3)
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.
PMID: 30357555DERIVEDMaltoni 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.
PMID: 27821313DERIVEDMaltoni 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.
PMID: 27472648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Maltoni, MD
IRST IRCCS, Meldola
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2013
First Posted
November 27, 2013
Study Start
August 1, 2012
Primary Completion
November 2, 2017
Study Completion
November 1, 2018
Last Updated
November 13, 2018
Record last verified: 2018-11