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

NCT ID: NCT02785887

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2018-09-25

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Oncological and geriatrician review

Routine oncological care plus geriatric intervention

Group Type: EXPERIMENTAL

Geriatrician review

Intervention Type: OTHER

In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found

Oncological care

Routine oncological care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Geriatrician review

In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL 4 Prato

OTHER

Sponsor Role: lead

Responsible Party

Laura Biganzoli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Biganzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL 4 Prato

Locations

Ospedale Vito Fazi

Lecce, , Italy

Ospedale San Paolo

Milan, , Italy

Istituto Oncologico Veneto

Padua, , Italy

Countries

Italy

Other Identifiers

GIVE

Identifier Type: -

Identifier Source: org_study_id