search
Back to results

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

Primary Purpose

Breast Cancer, Lung Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Geriatrician review
Sponsored by
Azienda USL 4 Prato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Vito Fazi
  • Ospedale San Paolo
  • Istituto Oncologico Veneto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oncological and geriatrician review

Oncological care

Arm Description

Routine oncological care plus geriatric intervention

Routine oncological care only

Outcomes

Primary Outcome Measures

Relative dose intensity
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.

Secondary Outcome Measures

Occurrence of treatment-related toxicity
Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Occurrence of hospitalization
Documentation of hospitalization
Early mortality
Documentation of death

Full Information

First Posted
March 26, 2014
Last Updated
February 14, 2019
Sponsor
Azienda USL 4 Prato
search

1. Study Identification

Unique Protocol Identification Number
NCT02785887
Brief Title
Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients
Acronym
GIVE
Official Title
Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL 4 Prato

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Bladder Cancer, Gastrointestinal Cancer
Keywords
Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oncological and geriatrician review
Arm Type
Experimental
Arm Description
Routine oncological care plus geriatric intervention
Arm Title
Oncological care
Arm Type
No Intervention
Arm Description
Routine oncological care only
Intervention Type
Other
Intervention Name(s)
Geriatrician review
Intervention Description
In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found
Primary Outcome Measure Information:
Title
Relative dose intensity
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Occurrence of treatment-related toxicity
Description
Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
every 3-4 weeks up to 6 months
Title
Occurrence of hospitalization
Description
Documentation of hospitalization
Time Frame
at 6 months for early and at 3 months for metastatic disease
Title
Early mortality
Description
Documentation of death
Time Frame
death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease
Other Pre-specified Outcome Measures:
Title
Optional Translational Substudy: Blood metabolites
Description
Proton Nuclear Magnetic Resonance (H-NMR) metabolomics spectra will be derived from a 10ml fasting peripheral serum sample collected prior to commencing chemotherapy
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any solid tumors 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 Absence of symptomatic central nervous system (CNS) metastases Eastern Cooperative Oncology group (ECOG) performance status 0-2 Estimated life expectancy of ≥ 12 weeks 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 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 Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule Exclusion Criteria: Age ≤ 69 years Any patients who did not meet the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Biganzoli, MD
Organizational Affiliation
Azienda USL 4 Prato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Vito Fazi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Ospedale San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs