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.
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:
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.
Other: Interventional arm: Early best palliative care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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.|
- Quality of Life (QoL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]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].
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Impact of families satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]The impact of families satisfaction about care will be evaluated by an Italian version of FAMCARE questionnaire.
- Overall survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]It is the time from the date of randomization to the date of death due to any cause.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Interventional arm
Other: Interventional arm: 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.
Other Name: Early best palliative care
No Intervention: Standard arm
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996540
|Palliative Care Clinic IRCCS IRST|
|Meldola, FC, Italy, 47014|
|U.O Oncologia medica|
|Lugo, RA, Italy, 48022|
|S. Donato, Arezzo|
|Centro di Riferimento Oncologico CRO|
|Ospedale degli Infermi,|
|Ospedale Businco, Cagliari|
|Policlinico Universitario, Cagliari|
|ASL AL, Casale Monferrato|
|Casale Monferrato, Italy|
|PO M.Santo, Cosenza|
|Istituti Ospitalieri, Cremona|
|S.Giovanni Di Dio, Firenze|
|Istituto Nazionale Tumori, Milano|
|Ospedale Sacco, Milano|
|Guglielmo da Saliceto|
|Arcispedale S. Maria Nuova|
|Reggio Emilia, Italy|
|Sora - Frosinone, Italy|
|AOP 9, Trapani|
|S. Maria Gruccia, Valdarno|
|AULSS 12, Venezia|
|Principal Investigator:||Marco Maltoni, MD||IRST IRCCS, Meldola|