Elderly CAncer Patient
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Oral opposition
Trial population
All patients aged 70 years or older, who had diagnosis of cancer (including hematologic malignancies), and referred to a getrician for GA in participating sites
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Extensive GA
Other interventionGA 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
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Elderly cancer patient cohort1 intervention
Trial outcomes
Primary outcomes
1
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
Time frame
through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).Secondary outcomes
1
Chemotherapy toxicities using Common Terminology Criteria for Adverse Events
Time frame
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).2
Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)
Time frame
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).3
Overall mortality
Time frame
Year 1 and 5 years follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
National Cancer Institute, France
Collaborator
Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne
Collaborator
Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest
Collaborator
Cancéropôle Ile De France
Collaborator
Source ClinicalTrials.gov