Clinical trial NCT01996540: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm
Gastric Neoplasm
Keywords: gastric neoplasm
pancreatic neoplasm
advanced
palliative care
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

   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.
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.

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: 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.

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:

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.

   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.
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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. patients eligible for chemotherapy and/or new target drugs treatments for metastatic or advanced disease;
3. ECOG PS 0-2 (Appendix A);
4. life expectancy \>2 months;
5. both sex;
6. age ≥18 years;
7. all ethnic background;
8. subjects who are, in the opinion of the Investigator, able to understand this study and to cooperate with the study procedures;
9. written informed consent (Appendix B);
10. palliative care visit must be performed by a dedicated physician/team different from the medical oncology group.

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 24 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24 months
measure: Impact of families satisfaction
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Palliative Care Clinic IRCCS IRST
state: FC
city: Lugo
country: Italy
facility: U.O Oncologia medica
state: RA
city: Arezzo
country: Italy
facility: S. Donato, Arezzo
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico CRO
city: Biella
country: Italy
facility: Ospedale degli Infermi,
city: Cagliari
country: Italy
facility: Ospedale Businco, Cagliari
city: Cagliari
country: Italy
facility: Policlinico Universitario, Cagliari
city: Casale Monferrato
country: Italy
facility: ASL AL, Casale Monferrato
city: Cesena
country: Italy
facility: Irst-Cesena
city: Como
country: Italy
facility: Sant'Anna
city: Cosenza
country: Italy
facility: PO M.Santo, Cosenza
city: Cremona
country: Italy
facility: Istituti Ospitalieri, Cremona
city: Ferrara
country: Italy
facility: Sant'Anna, Ferrara
city: Firenze
country: Italy
facility: S.Giovanni Di Dio, Firenze
city: Firenze
country: Italy
facility: S.Maria Annunziata,
city: Genova
country: Italy
facility: E.O. Galliera
city: Mestre
country: Italy
facility: Aulss 12,
city: Milano
country: Italy
facility: Istituto Nazionale Tumori, Milano
city: Milano
country: Italy
facility: Ospedale Sacco, Milano
city: Milano
country: Italy
facility: S.PAOLO
city: Padova
country: Italy
facility: IOV
city: Pavia
country: Italy
facility: San Matteo
city: Piacenza
country: Italy
facility: Guglielmo da Saliceto
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: Fatebenefratelli,
city: Sora - Frosinone
country: Italy
facility: SS Trinità,
city: Torino
country: Italy
facility: Gradinego
city: Trapani
country: Italy
facility: AOP 9, Trapani
city: Valdarno
country: Italy
facility: S. Maria Gruccia, Valdarno
city: Venezia
country: Italy
facility: AULSS 12, Venezia
Study officials:
affiliation: IRST IRCCS, Meldola
name: Marco Maltoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.