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

Azienda USL 4 Prato

Status: Completed

Conditions: Breast Cancer; Bladder Cancer; Gastrointestinal Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer

Treatments: Other: Geriatrician review

Study type: Interventional

Funder types: Other

Identifiers

NCT02785887

GIVE

Details and patient eligibility

About

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).

Full 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

Enrollment: 233 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

233 participants in 2 patient groups

Oncological and geriatrician review

Experimental group

Description:

Routine oncological care plus geriatric intervention

Treatment:

Other: Geriatrician review

Oncological care

No Intervention group

Description:

Routine oncological care only