MOST: Mediterranean Oncology Senior Tests

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

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Key information

Conditions

Colon Cancer Patients Receiving Chemotherapy in the Adjuvant or Metastatic Setting Aged 70 or Older Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Aix en Provence, Aix-en-Provence, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty markers

Other

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: Mobility, Strength, Energy, Physical activity, Nutrition

Primary outcomes

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).

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Association Sud pour la Recherche en Oncogériatrie

Other

Registry information

Official study title

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

Acronym: MOST

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2015
First posted: May 28, 2014
Registry last updated: Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed