Elderly CAncer Patient

Hematologic Malignancies Clinical Trial

— ELCAPA  

Official title:

Elderly Cancer Patient: ELCAPA Cohort Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02884375
• Other study ID #: UG 6729 UCOG
• Status: Recruiting
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 25, 2016
• Start date: September 2010
• Est. completion date: November 2027

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: PHILIPPE CAILLET, MD
• Phone: (0)149814707
• Email: philippe.caillet[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Malignancies
• Solid Cancer

Intervention

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

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (5)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Cancéropôle Ile De France, National Cancer Institute, France, Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest, Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	Overall mortality		Year 1 and 5 years follow-up	No