NCT03101631

Brief Summary

The Comprehensive Geriatric Assessment (CGA) is, still today, barely established in the standard practice. Although the different scientific societies recommend a CGA in elderly population affected with cancer at first visit, the evidence regarding its transcendence is limited. On the other hand, the components of this evaluation and the translation of their findings in changes in the clinical practice are not stablished. This project intends to implement a CGA in a group of patients to compare this group with an historical cohort that reflects the standard practice, to evaluate the differences between both approaches. The study also evaluate the feasibility and utility of this CGA. All these questions aims to support the hypothesis that CGA impacts on the cancer treatment for elderly population affected with cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

March 17, 2017

Last Update Submit

May 26, 2017

Conditions

FragilityCancer

Keywords

Elderly population with cancerToxicity riskMortality riskFrailty conditions in elderly populationChemotherapy in elderly population

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment related adverse events as assessed by CTCAE v4.0

    Evaluate occurrence of toxicity in both groups, experimental and control

    6 months

Secondary Outcomes (7)

  • Number of participants with occurrence of early mortality

    6 months

  • Number of Hospitalizations

    6 months

  • Number of participants with changes in cancer treatment related to toxicity

    6 months

  • Number of participants with a change in therapeutic decision related to CGA

    6 months

  • Contribution of different components of CGA to the management fo cancer

    6 months

  • +2 more secondary outcomes

Study Arms (2)

CASE ARM

EXPERIMENTAL

This is a three cohorts arm with intervention (CGA): * Nutritional Assessment: Mini Nutritional Assessment (MNA) * Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss. * Cognitive Assessment: Mini-Mental State Examination (MMSE-30) * Psychological status: Geriatric Depression Scale (GDS) * Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS) * Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27) * Age * Haemoglobin * Creatinine Clearance (CrCl) * Presence of Geriatric Syndromes

Diagnostic Test: Comprehensive Geriatric Assessment (CGA)

CONTROL ARM

NO INTERVENTION

This is a three cohorts arm with no intervention

Interventions

Comprehensive Geriatric Assessment (CGA)DIAGNOSTIC_TEST

CGA includes a set of evaluations to determine therapeutic decision based on mortality risk, toxicity risk and frailty group. Evaluations includes: * Nutritional Assessment: Mini Nutritional Assessment (MNA) * Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss. * Cognitive Assessment: Mini-Mental State Examination (MMSE-30) * Psychological status: Geriatric Depression Scale (GDS) * Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS) * Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27) * Age * Haemoglobin * CrCl * Presence of geriatric syndromes

Also known as: Frailty Evaluation
CASE ARM

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age more than 70 years
  • Outpatients
  • Patients diagnosed with stage III colon cancer, stage IV colorectal cancer or stage IV NSCLC
  • No previous diagnosis of cancer.
  • No previous chemotherapy for current diagnosis of cancer
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Javier Gallego, PhD

    HOSPITAL GENERAL UNIVERSITARIO DE ELCHE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Cases and Contols Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 5, 2017

Study Start

January 2, 2014

Primary Completion

July 30, 2014

Study Completion

January 30, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share