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

NCT02785887 | Completed

• 1 other identifier: GIVE
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

Breast cancer; lung cancer; Gastrointestinal Cancer; Ovarian cancer; Prostate cancer; bladder cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Occurrence of treatment-related toxicity

  every 3-4 weeks up to 6 months

• Occurrence of hospitalization

  at 6 months for early and at 3 months for metastatic disease

• Early mortality

  death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease

Other Outcomes (1)

• Optional Translational Substudy: Blood metabolites

  up to 12 months

Study Arms (2)

Oncological and geriatrician review

EXPERIMENTAL

Routine oncological care plus geriatric intervention

Other: Geriatrician review

Oncological care

NO INTERVENTION

Routine oncological care only

Interventions

Geriatrician review OTHER

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

Oncological and geriatrician review

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age ≤ 69 years

Sponsors & Collaborators

• Azienda USL 4 Prato: lead

Study Sites (3)

Ospedale Vito Fazi

Lecce, 73100, Italy

Location

Ospedale San Paolo

Milan, 20142, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Laura Biganzoli, MD

  Azienda USL 4 Prato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: May 30, 2016
• Study Start: August 1, 2014
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)