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Elderly CAncer Patient

NCT02884375 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2016-08-31

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

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

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne

    collaborator UNKNOWN

  • Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest

    collaborator UNKNOWN

  • Cancéropôle Ile De France

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • PHILIPPE CAILLET, MD · Assistance Publique - Hôpitaux de Paris

  • ELENA PAILLAUD, MD-PhD · Assistance Publique - Hôpitaux de Paris

  • FLORENCE CANOUI-POITRINE, MD-PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02884375 on ClinicalTrials.gov