Frailty Evaluation in Elderly Population With Cancer (ELDERLY)

May 26, 2017 updated by: Javier Gallego Plazas, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Exploratory Study of Frailty Evaluation in Elderly Population With Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study compares two groups of elderly patients affected with stage IV non-small lung cancer (NSCLC), stage III colon cancer and stage IV colorectal cancer (CRC): a prospective experimental cohort and an historic control cohort. The sample size is 60 patients, 30 prospective and 30 retrospective. Of each cohort, 10 patients have stage IV NSCLC, 10 have stage III colon cancer and 10 have stage IV CRC. Prospective patients will be recruited longitudinally from January 2013 and retrospective patients are recorded longitudinally backward in time from December 2012. Both groups are patients of Medical Oncology Service of Hospital General Universitario de Elche, and both groups sign an informed consent form.

A CGA is performed in the experimental group after the first visit with oncologist and prior to therapeutic decision. This CGA 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)

The evaluation includes too age, haemoglobin, Creatinine Clearance (CrCl) and presence of geriatric syndromes.

The results of this evaluation allow to calculate:

  • Early mortality risk according to Soubeyran et al (JCO 2012, 30: 1829-1834) (MNA and Get up and Go):
  • risk of early mortality
  • no risk of early mortality.
  • Toxicity to chemotherapy according to Hurria et al. (J Clin Oncol 2011, 29: 3457-3465) (age, type of cancer, dose and number of chemotherapy drugs, haemoglobin, CrCl, hearing loss, number of falls in last 6 months, ability to take medication without help (IADL), walking one block and social support (MOS-SSS):
  • low risk
  • medium risk
  • high risk.
  • Frailty group according Köhne et al (The Oncologist 2008, 13: 390-402) (ADL, IADL, comorbidity and severity of comorbidities and presence of geriatric syndromes). This information dictates the therapeutic strategy for each experimental patient:
  • Group 1: standard treatment.
  • Group 2: modified treatment
  • Group 3: no treatment

Experimental patients will be followed for six months from CGA and their toxicity and its severity, occurrence of treatment modifications, number of hospitalizations and reasons for hospitalizations and mortality and reason of mortality will be compared with the same items of historic controls, followed too for six months from the moment the physician made the therapeutic decision.

Other data to record for both groups: sex, age, origin, leucocytes, platelets, LDH, albumin, CEA, Cr Cl, haemoglobin, subjective weight loss, corporal mass index, comorbidities, primary tumor: stage, metastases location, treatment intent: adjuvant, palliative, number of drugs, number of concomitant medications, PS according to ECOG and Karnofsky (some data are expected to be missing for historic group).

Only for historic controls, physicians should answer one question : In wich category would include the treatment recommendation? according to Köhne, The Oncologist 2008: Balducci, The Oncologist 2000; J Clin Oncol 2012:

  • standard treatment
  • modified treatment
  • no treatment despite treatment is recommended
  • no treatment

Only for historic controls two more questions should be answered:

  • Has a Geriatric Evaluation been performed? Yes or No
  • What sort of evaluation?

The trial records too how long does it take each test and how long does it take to complete CGA.

All information is recorded in a database with anonymous code for each subject.

Statistical analysis will consist of a descriptive analysis of sociodemographic and clinical characteristics of both cohorts. It will be performed also non-parametric analysis comparing this characteristics between the experimental groups. A descriptive analysis of daily life characteristics in experimental group will be performed, and also a non-parametric analysis comparing these variables between the experimental groups.

Changes due to CGA incorporation will be evaluated and the variables measuring the toxicity and early mortality should be correlated to the coincidence or not of the treatment performed with the one concluded by the geriatric evaluation.

Contribution of the different elements of CGA will be evaluated. A multiple regression will be performed in order to carry out an evaluation of the degree of contribution of each of the elements of the CGA.

A significance "p" less than 0.05 will be considered significant.

There are some study limitations: size, missing data for historic patients, monocentric study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not fulfilling inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CASE ARM

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)

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
Other Names:
  • Frailty Evaluation
NO_INTERVENTION: CONTROL ARM
This is a three cohorts arm with no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months
Evaluate occurrence of toxicity in both groups, experimental and control
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with occurrence of early mortality
Time Frame: 6 months
Evaluate occurrence of early mortality in both groups, experimental and control
6 months
Number of Hospitalizations
Time Frame: 6 months
Evaluate occurrence of hospitalizations in both groups, experimental and control
6 months
Number of participants with changes in cancer treatment related to toxicity
Time Frame: 6 months
Evaluate changes in treatment in both groups, experimental and control
6 months
Number of participants with a change in therapeutic decision related to CGA
Time Frame: 6 months
Evaluate impact in the treatment for cancer in elderly population with NSCLC stage IV, colon cancer stage III and CRC stage IV of a CGA
6 months
Contribution of different components of CGA to the management fo cancer
Time Frame: 6 months
Analysis of the weight of ech component through multiple regression
6 months
Impact of CGA in health care in terms of human recourses and time consumption
Time Frame: Baseline
Cost of CGA measured in minutes for each component of CGA and person
Baseline
Predictive factors of events related to treatment
Time Frame: 6 months
To detect wich conditions predispose to adverse events
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELDERLY V 1.0 20DEC2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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