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

Sponsor

Azienda USL 4 Prato (Other)

Overall Status

Completed

CT.gov ID

NCT02785887

Collaborator

(none)

233

Enrollment

Locations

Arms

49.8

Actual Duration (Months)

77.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Lung Cancer Ovarian Cancer Prostate Cancer Bladder Cancer Gastrointestinal Cancer	Other: Geriatrician review	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

233 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Sep 25, 2018

Actual Study Completion Date :

Sep 25, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Relative dose intensity [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.

Secondary Outcome Measures

Occurrence of treatment-related toxicity [every 3-4 weeks up to 6 months]
Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Occurrence of hospitalization [at 6 months for early and at 3 months for metastatic disease]
Documentation of hospitalization
Early mortality [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

Other Outcome Measures

Optional Translational Substudy: Blood metabolites [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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