MOST: Mediterranean Oncology Senior Tests (MOST)

January 11, 2019 updated by: Association Sud pour la Recherche en Oncogériatrie

Longitudinal Study Comparing Markers of Frailty in Geriatric Assessment to Detect Vulnerability to Chemotherapy in Patients Aged 70 Years or Older With Colon Cancer

MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are better at detecting vulnerable patients and that they are a better "Adverse Events" predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients referred for chemotherapy. The second hypothesis is that a brief screening tool based on a combination of some frailty markers and some used in the CGA would help the oncologist detect patients requiring a more complete geriatric assessment

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

For older cancer patients, Comprehensive Geriatric Assessment (CGA) is recommended in order to help the oncologist in his decision making. However, the implementation of the CGA in oncologic setting presents major limitations; The CGA is time consuming, costly in terms of resources and is not standardized. Moreover, recent studies show that the CGA, used as the gold standard, may have a ceiling effect in detecting vulnerability in older cancer patients. Several authors suggest that a more sensitive approach, using frailty markers may be a better way to detect potential vulnerability in older cancer patients. In this study, for each patient, a brief screening assessment, a full CGA and the assessment of frailty markers will be completed at inclusion. The brief screening assessment will be based on self report questionnaire (4 items of instrumental Activities of Daily Living + 2 items of nutritional assessment) and one physical measure (one-leg standing balance test). The CGA will be based on seven domains (and their assessment tools): functional status, comorbidities, objective physical performance, nutrition, cognition, depression, and social support. Five frailty markers (as described by Fried and al) will be evaluated: nutrition, mobility, energy, physical activity and grip strength. CGA and frailty markers will be completed at 3, 6, 12 and 18 months after the beginning of chemotherapy as well as oncologic criteria (treatment toxicities, treatment modification such as decrease or change or end of chemotherapy, percentage of chemotherapy dose received, cancer related death) and geriatric criteria for adverse outcomes (functional, nutritional or cognition decline, hospitalization or consultation with their general practitioner, death for other causes).

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.
Observational

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.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France
        • Hopital d'Aix en Provence
      • Draguignan, France
        • Centre Hospitalier de la Dracénie
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Marseille, France, 13003
        • Hôpital Européen Marseille
      • Nice, France, 06000
        • Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique
      • Pontoise, Val-d'Oise, France, 95300
        • Hôpital de Pontoise Centre Hospitalier René Dubos
      • Sisteron, France
        • Centre Hospitalier Universitaire Intercommunal des Alpes du Sud
      • Toulon, France
        • Centre Hospitalier Intercommunal

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

Sampling Method

Non-Probability Sample

Study Population

Elderly colon cancer patients, recruited from 6 different oncology centers in France.

Description

Inclusion Criteria:

  • Patients with colon cancer with or without metastases
  • Age ≥ 70 years
  • Patients did not start chemotherapy yet

Exclusion Criteria:

  • Patients terminally ill with a life expectancy <3 months
  • Patients who have started chemotherapy or hormonal therapy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Comprehensive Geriatric Assessment (CGA)
Functional status, Comorbidities, Objective physical performance, Nutrition, Cognition, Depression, Social support
Other: Frailty markers
Brief screening assessment, CGA and frailty markers will be evaluate at inclusion. CGA and frailty markers will be evaluated at 3, 6, 12 and 18 months after the beginning of chemotherapy. Criteria for toxicity and adverse outcomes will be recorded at each cycle or visits
Other Names:
  • Physical activity
  • Nutrition
  • Strength
  • Mobility
  • Energy

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
Occurrence of Adverse Events
Time Frame: up to 18 months
The primary endpoint analysis is defined by the relationship between the CGA (Comprehensive Geriatric Assessment) and frailty markers on the one hand and the occurrence of adverse events on the other. The effect of each tool will be evaluated using a Cox model. The results will be adjusted on the main prognostic factors (age, type and stage of cancer).
up to 18 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
Performance of the brief screening tool
Time Frame: 3, 6, 12 and 18 months
A second analysis will also evaluate the performance of the brief screening tool by determining its efficiency (specificity, sensitivity, positive and negative predictive values and accuracy) within the sample population in comparison to the CGA's and frailty markers. Estimations will be computed with a 95 % confidence interval.
3, 6, 12 and 18 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.
Association Sud pour la Recherche en Oncogériatrie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frédérique RETORNAZ, MD, Association Sud pour la Recherche en Oncogériatrie

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.

General Publications

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 1, 2010

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.
December 1, 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.
December 1, 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).
May 23, 2014

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.
May 27, 2014

First Posted (Estimate)

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.
May 28, 2014

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.
January 15, 2019

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.
January 11, 2019

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.
January 1, 2019

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.
  • ASRO101

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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