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NCT Number: NCT02884375

Elderly CAncer Patient

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

Recruiting

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Solid Cancer

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extensive GA

Other

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

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-up

Study contacts

Contact information is provided by the study sponsor or research team.

PHILIPPE CAILLET, MD

CONTACT

[email protected]

(0)149814707 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cancéropôle Ile De France
  • National Cancer Institute, France
  • Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest
  • Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne

Registry information

Official study title

Elderly Cancer Patient: ELCAPA Cohort Survey

Acronym: ELCAPA

Important dates

Study start
2010
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2016
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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