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Идёт набор NCT02884375

Elderly CAncer Patient

— Наблюдательное Hematologic Malignancies Solid Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Extensive GA.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancies, Solid Cancer. Базовые параметры: от 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Elderly Cancer Patient: ELCAPA Cohort Survey

Обзор

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

Вмешательства

  • Другое 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), histor

Первичные конечные точки

  • Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment [Срок оценки: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).]
Вторичные конечные точки (3)
  • Chemotherapy toxicities using Common Terminology Criteria for Adverse Events [Срок оценки: 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) [Срок оценки: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).]
  • Overall mortality [Срок оценки: Year 1 and 5 years follow-up]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Oral opposition

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Henri Mondor Hospital — Créteil

Публикации

  • 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. PMID 36306481
  • 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. PMID 32889525

Идентификаторы

NCT: NCT02884375 · UG 6729 UCOG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗