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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier:
NCT01996540
First received: November 22, 2013
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Pancreatic Neoplasm
Gastric Neoplasm
Other: Interventional arm: Early best palliative care

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:

Primary Outcome Measures:
  • 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].


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 240
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional arm
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
Standard arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996540

Contacts
Contact: Oriana Nanni, PhD +390543739266 oriana.nanni@irst.emr.it

Locations
Italy
Palliative Care Clinic IRCCS IRST Recruiting
Meldola, FC, Italy, 47014
Contact: Marco Maltoni, MD    +39 0543733333    ma.maltoni@ausl.fo.it   
Principal Investigator: Marco Maltoni, MD         
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
Principal Investigator: Marco Maltoni, MD IRST IRCCS, Meldola
  More Information

No publications provided

Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT01996540     History of Changes
Other Study ID Numbers: IRST100.08
Study First Received: November 22, 2013
Last Updated: June 18, 2015
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
gastric neoplasm
pancreatic neoplasm
advanced
palliative care

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Pancreatic Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 29, 2015