Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Low Grade Non-Hodgkin's Lymphoma, Adult. 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
- 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
Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
Обзор
Aims of this study are to describe the variation of QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).
Подробное описание
This is a prospective, multicenter, non-interventional study aiming at investigating on the changes in QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to possibly identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).
The study plans to enroll 150 patients with a local histologically confirmed diagnosis of indolent non-Hodgkin lymphoma fulfilling all the inclusion/exclusion criteria who provide written informed consent will be included in the study. Any type of treatment is allowed by the study (immunotherapy, immunochemotherapy at full or reduced dose, radiotherapy).
All patients must undergo Comprehensive Geriatric Assessment (CGA) before starting any protocol treatment.
Baseline, post-treatment and follow-up instrumental assessments and response evaluation is done as part of the routine clinical management for patients with indolent NHL (Non Hodgkin Lymphoma) . Response evaluation and all other assessments planned for the EOT (end of treatment) should be planned also in case of early withdrawal, according to clinical practice.
HRQoL (Health-related Quality of Life) evaluation will be done at time of informed consent form signature prior to treatment start, at the end of the treatment (ranging from 1 month to 6 months according to the duration of the treatment) and after 1 year from the start of the therapy.
QoL (quality of life) assessment includes all scales of the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire-Core 30) and the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma - lymphoma-specific symptoms questionnaire).
Первичные конечные точки
- QoL (quality of life) scores at baseline - EORTC-QLQ-C30 [Срок оценки: The endpoint wil be evaluated at the baseline.]
- QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30 [Срок оценки: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)]
- QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30 [Срок оценки: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)]
- QoL (quality of life) scores at baseline - FACT-Lym-LymS [Срок оценки: The endpoint wil be evaluated at the baseline.]
- QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS [Срок оценки: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)]
- QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS [Срок оценки: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)]
Вторичные конечные точки (5)
- Overall Survival (OS) [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)]
- Progression-Free Survival (PFS) [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)]
- Event-Free Survival (EFS) [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)]
- Overall Response Rate (ORR) [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)]
- Registration of safety [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)]
Критерии участия
Критерии включения
- Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicular lymphoma, marginal zone lymphoma (nodal, MALT (Mucosa-Associated Lymphoid Tissue), splenic), lymphoplasmacytic lymphoma/ Waldenström macroglobulinemia)
- Age ≥ 70 years
- Patient candidates to receive treatment for lymphoma
- Patient previously untreated for lymphoma
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Ability to provide informed consent: subject understands and voluntarily signs an informed consent form approved by an IEC (Independent Ethics Committee), prior to registration into the study
Note: Patient treated in the context of a clinical trial is admitted
Критерии исключения
- none
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 20 центров
- S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo — Alessandria
- Clinica di Ematologia - A.O.U. Ospedali Riuniti — Ancona
- U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II — Bari
- Ematologia - ASST Spedali Civili di Brescia — Brescia
- Ematologia - Ospedale di Castelfranco Veneto — Castelfranco Veneto
- U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco — Catania
- Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi — Florence
- S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte — Messina
- … и ещё 12 центров
Идентификаторы
NCT: NCT05524298 · FIL_QoL-ELDIND