Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients (GIVE)

February 14, 2019 updated by: Laura Biganzoli, Azienda USL 4 Prato

Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial

This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable [≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)] elderly cancer patients with early stage or advanced solid organ malignancies.

Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care

Study Type

Interventional

Enrollment (Actual)

233

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
      • Lecce, Italy, 73100
        • Ospedale Vito Fazi
      • Milano, Italy, 20142
        • Ospedale San Paolo
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Any solid tumors
  2. Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting
  3. Absence of symptomatic central nervous system (CNS) metastases
  4. Eastern Cooperative Oncology group (ECOG) performance status 0-2
  5. Estimated life expectancy of ≥ 12 weeks
  6. At least 1 deficit identified on CGA at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by CIRS-G
  7. Written informed consent in according to International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use/Good Clinical Practice (ICH/GCP), and national/local ethics regulations
  8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule

Exclusion Criteria:

  1. Age ≤ 69 years
  2. Any patients who did not meet the inclusion criteria

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncological and geriatrician review
Routine oncological care plus geriatric intervention
Other: Geriatrician review
In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found
No Intervention: Oncological care
Routine oncological care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative dose intensity
Time Frame: 6 months
Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment-related toxicity
Time Frame: every 3-4 weeks up to 6 months
Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
every 3-4 weeks up to 6 months
Occurrence of hospitalization
Time Frame: at 6 months for early and at 3 months for metastatic disease
Documentation of hospitalization
at 6 months for early and at 3 months for metastatic disease
Early mortality
Time Frame: death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease
Documentation of death
death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optional Translational Substudy: Blood metabolites
Time Frame: up to 12 months
Proton Nuclear Magnetic Resonance (H-NMR) metabolomics spectra will be derived from a 10ml fasting peripheral serum sample collected prior to commencing chemotherapy
up to 12 months

Collaborators and Investigators

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

Sponsor

Azienda USL 4 Prato

Investigators

  • Principal Investigator: Laura Biganzoli, MD, Azienda USL 4 Prato

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, 2014

Primary Completion (Actual)

September 25, 2018

Study Completion (Actual)

September 25, 2018

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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