MOST: Mediterranean Oncology Senior Tests

Completed

• Conditions: Aged 70 or Older; Colon Cancer Patients Receiving Chemotherapy in the Adjuvant or Metastatic Setting

• Registration Number: NCT02148731
• Lead Sponsor: Association Sud pour la Recherche en Oncogériatrie

Brief Summary

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

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Events	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 Outcome Measures

Name	Time	Method
Performance of the brief screening tool	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.

Trial Locations

Locations (8)

Hôpital d'Aix en Provence; 🇫🇷 Aix en Provence, France

Centre Hospitalier de la Dracénie; 🇫🇷 Draguignan, France

Hôpital Européen Marseille; 🇫🇷 Marseille, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique; 🇫🇷 Nice, France

Hôpital de Pontoise Centre Hospitalier René Dubos; 🇫🇷 Pontoise, Val-d'Oise, France

Centre Hospitalier Universitaire Intercommunal des Alpes du Sud; 🇫🇷 Sisteron, France

Centre Hospitalier Intercommunal; 🇫🇷 Toulon, France