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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Association Sud pour la Recherche en Oncogériatrie

Investigators

  • 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)

January 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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