Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis

Официальное название

Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis

Обзор

The purpose of this study is to determine the impact on anxiety between patients with a period of care support following their announcement of an acute leukemia (AL) diagnosis and patients without this accompaniment.

Подробное описание

Patients answering the inclusion and exclusion criteria will be offered the opportunity to participate in the study by a nurse trained in this method of period of care support at the time of their announcement of an AL diagnosis. Patients will be given sufficient time to consider their decision. Following this period, patients who wish to participate will be included in the study, will sign the informed consent form and will be randomized (with or without a period of care support following their announcement of an AL diagnosis).

Patients in both groups will have their anxiety and quality of life questionnaire (QLQ-C30) assessed within the context of their usual care at T0 (at the time of the announcement).

Patients randomized in the arm with period of care support meet the nurse for this accompaniment within 7 days after the announcement.

Patients in both groups will have their anxiety at T1 (within 24 hours after the period of care support for the experimental group, same timeframe for the control group), and again their anxiety and quality of life at T2, two months (± 3 days) after admission to the intensive care unit. An evaluation questionnaire concerning period of care support will be given to the group benefiting from this care and a satisfaction questionnaire for the care will be given to patients in both groups at T2.

Вмешательства

• Другое care support program after diagnosis announcement
  a dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated

Первичные конечные точки

• Anxiety improvment [Срок оценки: 7 days after diagnosis announcement]

Критерии участия

Критерии включения

• informed consent signed
• medical confirmation of acute leukemia diagnosis
• age equal of superior to 26 years and under 80 years
• confirmed diagnosis not yet treated
• hospitalization at Centre Henri Becquerel
• member or beneficiary of a social security

Критерии исключения

• -Patient unable to understand the study for any reason or to comply with the trial's requirements
• Patient in relapse of acute leukemia
• Patient diagnosed with acute myeloid leukemia 3
• History of cancer within the 5 years preceding the year of study enrollment
• Alcohol and drug abuse
• Inclusion in another therapeutic trial that prevents further enrollment in a trial evaluating quality of life or psychological well-being
• Diagnosed psychiatric illness
• Patient under guardianship, curatorship, or legal protection

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Henri Becquerel — Rouen

Идентификаторы

NCT: NCT07499765 · CHB25.01 · 2025-A00060-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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