Elderly CAncer Patient

Study Overview
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Brief Summary
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The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations. Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment. The objectives are: To assess the role of GA for decision making process for older patients with cancer To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities To develop and/or validate screening tests for frailty in geriatric oncology To develop and validate frailty classifications Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals

Official Title
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Elderly Cancer Patient: ELCAPA Cohort Survey

Conditions
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Hematologic Malignancies, Solid Cancer

Intervention / Treatment
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* Other: Extensive GA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 70 years or older Diagnosed cancer at all stage Referred to a geriatrician for GA Given oral non-opposition from patient or a legally mandated person Exclusion Criteria: Oral opposition

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly cancer patient cohort<br>Patients aged 70 years or older, who had diagnosis of cancer in participating sites (including hematologic malignancies), and referred to a geriatrician for geriatric assessment (GA) | Other: Extensive GA<br>* GA includes an evaluation of nine domains according to international recommendations : functional status (six-item Activities of Daily Living (ADL) score, Instrumental Activities of Daily Living (IADL)) mobility (timed get-up-and-go test, one-leg standing balance test, history of fall) nutritional status (French National Authority of Health guidelines, weight loss body mass index (BMI), Mini Nutritional Assessment, albumin ) cognitive status (Mini-Mental State Examination (MMSE), history of dementia, confusion) mood (Mini-Geriatric Depression Scale (Mini-GDS), symptoms of anxiety, depression (DSM V)) comorbidities (CIRS G) polypharmacy (number of medications) social environment (primary caregiver, support at home, friends , family, living alone) urinary and/or fecal incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment |  | through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy toxicities using Common Terminology Criteria for Adverse Events |  | through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols). | 
| Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status) |  | through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols). | 
| Overall mortality |  | Year 1 and 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Cancer, Geriatric assessment, Treatment, Epidemiology