NCT02785887

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Azienda USL 4 Prato · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer
• Bladder Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2016-05-30
• Last updated: 2019-02-15

Locations

3 sites across 1 country: Italy