Elderly CAncer Patient (ELCAPA)

August 25, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Elderly Cancer Patient: ELCAPA Cohort Survey

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Creteil, France, 94010
        • Recruiting
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
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).
through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).
Overall mortality
Time Frame: Year 1 and 5 years follow-up
Year 1 and 5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

Investigators

  • Principal Investigator: PHILIPPE CAILLET, MD, Assistance Publique - Hôpitaux de Paris
  • Study Director: ELENA PAILLAUD, MD-PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: FLORENCE CANOUI-POITRINE, MD-PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2027

Study Completion (ANTICIPATED)

November 1, 2027

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UG 6729 UCOG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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