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.

November 8, 2018 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Early best palliative care
No Intervention: Standard arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 24 months
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.
24 months
Impact of families satisfaction
Time Frame: 24 months
The impact of families satisfaction about care will be evaluated by an Italian version of FAMCARE questionnaire.
24 months
Overall survival (OS)
Time Frame: 24 months
It is the time from the date of randomization to the date of death due to any cause.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

  • Principal Investigator: Marco Maltoni, MD, IRST IRCCS, Meldola

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRST100.08

Plan for Individual participant data (IPD)

Study Data/Documents

  1. study publication
    Information comments:

    Maltoni M et al Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial.

    Eur J Cancer 2016 Sep;65:61-8

  2. study publication
    Information comments:

    Maltoni M et al 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.

  3. study publication
    Information comments:

    Scarpi E. et al

    Systematic vs. on-demand early palliative care in gastric cancer patients:

    a randomized clinical trial assessing patient and healthcare service outcomes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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