Clinical trial NCT02148731: MOST: Mediterranean Oncology Senior Tests
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer Patients Receiving Chemotherapy in the Adjuvant or Metastatic Setting
Aged 70 or Older
Keywords: Colon cancer
Elderly patients
Lead sponsor: Association Sud pour la Recherche en Oncogériatrie
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 180
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly colon cancer patients, recruited from 6 different oncology centers in France.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Adverse Events
timeFrame: up to 18 months
Secondary outcomes:
measure: Performance of the brief screening tool
timeFrame: 3, 6, 12 and 18 months
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Hôpital d'Aix en Provence
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie
city: Marseille
country: France
facility: Hôpital Européen Marseille
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nice
country: France
facility: Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique
city: Pontoise, Val-d'Oise
country: France
facility: Hôpital de Pontoise Centre Hospitalier René Dubos
city: Sisteron
country: France
facility: Centre Hospitalier Universitaire Intercommunal des Alpes du Sud
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
affiliation: Association Sud pour la Recherche en Oncogériatrie
name: Frédérique RETORNAZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Retornaz F, Seux V, Sourial N, Braud AC, Monette J, Bergman H, Soubeyrand J. Comparison of the health and functional status between older inpatients with and without cancer admitted to a geriatric/internal medicine unit. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):917-22. doi: 10.1093/gerona/62.8.917.
citation: Retornaz F, Monette J, Batist G, Monette M, Sourial N, Small D, Caplan S, Wan-Chow-Wah D, Puts MT, Bergman H. Usefulness of frailty markers in the assessment of the health and functional status of older cancer patients referred for chemotherapy: a pilot study. J Gerontol A Biol Sci Med Sci. 2008 May;63(5):518-22. doi: 10.1093/gerona/63.5.518.