Clinical trial NCT02884375: Elderly CAncer Patient
Official title: Elderly Cancer Patient: ELCAPA Cohort Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancies
Solid Cancer
Keywords: Elderly
Cancer
Geriatric assessment
Treatment
Epidemiology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne
name: Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest
name: Cancéropôle Ile De France
First posted: 2016-08-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
timeFrame: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).
Secondary outcomes:
measure: Chemotherapy toxicities using Common Terminology Criteria for Adverse Events
timeFrame: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
measure: Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)
timeFrame: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).
measure: Overall mortality
timeFrame: Year 1 and 5 years follow-up
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: PHILIPPE CAILLET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: ELENA PAILLAUD, MD-PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: FLORENCE CANOUI-POITRINE, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2023 Feb 1;41(4):826-834. doi: 10.1200/JCO.22.01118. Epub 2022 Oct 28.
citation: Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canoui-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2021 Jan;113(1):129-141. doi: 10.1093/ajcn/nqaa238. Epub 2020 Sep 5.