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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Bladder Cancer, Gastrointestinal Cancer

Intervention / Treatment
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* Other: Geriatrician review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment-related toxicity | 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 | Documentation of hospitalization | at 6 months for early and at 3 months for metastatic disease | 
| Early mortality | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer