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Идёт набор NCT06085716

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Фаза II / Фаза III С лечением Metastatic Cancers Fatigue

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: Psychoeducational Intervention, Open Label Placebo, Psychoeducational Intervention+Placebo.
Кому может быть актуально
Состояния в реестре: Metastatic Cancers, Fatigue. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Подробное описание

Primary Objectives:

1\. To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.

We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.

Secondary Objectives:

1\. To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment

3\. To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).

We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.

Вмешательства

  • Поведенческое Psychoeducational Intervention
    Participants in the PI group will complete the educational sessions only.
  • Препарат Open Label Placebo
    This group will only take placebo capsules every day.
  • Поведенческое Psychoeducational Intervention+Placebo
    This group will take the placebo capsules every day, as well as completing the educational sessions.

Первичные конечные точки

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Срок оценки: through study completion; an average of 1 year]

Критерии участия

Критерии включения

  • Be advanced cancer patients or s or have a history of advanced cancer, having fatigue with severity of ≥ 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale), and presence of fatigue for at least 2 weeks.
  • Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
  • Be aged 18 years or older.
  • Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
  • Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
  • Be able to understand the description of the study and sign a written informed consent.
  • Have a ECOG performance status score of 0 to 2; and
  • Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)
  • Able to read, write and speak English

Критерии исключения

  • Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.
  • Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
  • Be pregnant (as documented in chart) or become pregnant while on study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • MD Anderson Cancer Centerr — Houston

Идентификаторы

NCT: NCT06085716 · 2023-0466 · NCI-2023-08682

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗