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Идёт набор NCT06299540

Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia

— Наблюдательное Leukemia, Lymphocytic, Chronic, B-Cell

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: Individual Physical Activity Intervention (IPAI), Ibrutinib.
Кому может быть актуально
Состояния в реестре: Leukemia, Lymphocytic, Chronic, B-Cell. Базовые параметры: от 18 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
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Официальное название

Benefits of an Individual Physical Activity Intervention on Health-related Quality of Life in Patients With Chronic Lymphocytic Leukemia Receiving Ibrutinib in Real-life Practice

Обзор

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

Вмешательства

  • Поведенческое Individual Physical Activity Intervention (IPAI)
    No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.
  • Препарат Ibrutinib
    No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Первичные конечные точки

  • Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5 [Срок оценки: Baseline and Month 4.5]
Вторичные конечные точки (12)
  • Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 [Срок оценки: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 [Срок оценки: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 [Срок оценки: Month 6.5 and Month 12]
  • Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 [Срок оценки: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 [Срок оценки: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 [Срок оценки: Month 6.5 and Month 12]
  • Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 [Срок оценки: Baseline, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 [Срок оценки: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 [Срок оценки: Month 6.5 and Month 12]
  • Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline [Срок оценки: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 [Срок оценки: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change From Baseline in Total Sleep Time Using Connected Watch [Срок оценки: Baseline, Month 4.5, Month 6.5, and Month 12]

Критерии участия

Критерии включения

  • Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum)
  • Participants agreed to follow the individual physical activity intervention (IPAI)
  • Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet
  • Participants with Internet access at home and email address
  • Participants agreed to wear a connected watch 24 hours a day for all the duration of the study

Критерии исключения

  • Pregnant participants or planning to become pregnant while enrolled in this study
  • Participants with inability or deemed unsafe to practice physical activity
  • Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit
  • Participants who are currently involved in an interventional study
  • Participants with probable difficulties in using the digital tool autonomously

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
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse

Идентификаторы

NCT: NCT06299540 · 54179060CLL4033 · 54179060CLL4033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗