Идёт набор NCT06937554

Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients

— Наблюдательное Acute Leukemia

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: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters.
Кому может быть актуально: Состояния в реестре: Acute Leukemia. Базовые параметры: 18 лет — 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: Италия
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

Evaluation of Physical-cognitive-functional and Nutritional Parameters in Inpatients Affected by Acute Leukemia During Intensive Chemotherapy Treatment

Обзор

This single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. Patients will provide informed consent prior to enrollment. Hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. Performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.

Подробное описание

This is an observational prospective longitudinal single-center study. All patients will be required to agree to participate in the study and to sign an informed consent prior to enrollment.

During the course of the study, the hematologists will manage the patients as per clinical practice and give clearance to perform each evaluation. All functional assessments and tests will be carried out by trained healthcare personnel with experience in the field of rehabilitation (either a Physical and Rehabilitation Medicine Resident, a Specialist, or a physiotherapist). A nutritionist will take care of assessing the nutritional aspects.

The aim of this study is to analyze the cognitive, physical and nutritional performance of AL patients hospitalized to receive intensive chemiotherapy (IC). Each item will be assessed at admission and discharge from the ward and after three weeks from the start of chemotherapy. Modifications of the considered items will be annotated and compared throughout the courses of chemotherapy, as well as relationship with indices of response and survival (Disease Free Survival, Overall Survival) will be explored. Such an effort will help further understanding how hematologic inpatients perform during IC treatment and what are the consequences on their quality of life and activities of daily living.

Вмешательства

Другое observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters

Первичные конечные точки

Grip Force Test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Modified Borg Scale (MBS) [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Tampa Scale of Kinesofobia (TSK) [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Timed Up and Go (TUG) [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Visual Analogue Scale (VAS) for pain [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Fatigue Severity Scale (FSS) [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Functional Ambulation Classification (FAC) [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
SF-12 Questionnaire [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Symbol Digit Modalities Test (SDMT) for processing speed [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Modified Barthel Index [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]

Вторичные конечные точки (5)

Coin test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Sock test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Back Scratch Test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Forward Bending Test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]
Stability test [Срок оценки: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)]

Критерии участия

Критерии включения

Age above 18 years
Patients affected by Acute Leukemia
Inpatients performing intensive chemotherapy
Patients with no restrictions on mobilization
Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.