Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2010-09-30
2027-11-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Elderly cancer patient cohort
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)
Extensive GA
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
Interventions
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Extensive GA
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
Eligibility Criteria
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Inclusion Criteria
* Diagnosed cancer at all stage
* Referred to a geriatrician for GA
* Given oral non-opposition from patient or a legally mandated person
Exclusion Criteria
70 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne
UNKNOWN
Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest
UNKNOWN
Cancéropôle Ile De France
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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PHILIPPE CAILLET, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
ELENA PAILLAUD, MD-PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
FLORENCE CANOUI-POITRINE, MD-PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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Central Contacts
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References
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Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2023 Feb 1;41(4):826-834. doi: 10.1200/JCO.22.01118. Epub 2022 Oct 28.
Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canoui-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2021 Jan;113(1):129-141. doi: 10.1093/ajcn/nqaa238. Epub 2020 Sep 5.
Other Identifiers
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UG 6729 UCOG
Identifier Type: -
Identifier Source: org_study_id