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Идёт набор NCT07186556

Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention

Без фазы С лечением Cancer Fatigue Brain Tumor Adult

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: RISE-YA Intervention, Survivorship Education.
Кому может быть актуально
Состояния в реестре: Cancer, Fatigue, Brain Tumor Adult. Базовые параметры: 18 лет — 39 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

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

Подробное описание

Primary Objective:

Test the efficacy of RISE-YA to improve CRF

Secondary Objectives:

1. Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors. 2. Determine A) cross-sectional associations of CRF with oxidative phosphorylation (OxPhos) and with inflammation, and B) the effect of RISE-YA on OxPhos and on inflammation.

Exploratory Objective:

Assess the effect of our supervised exercise intervention on patient-reported health-related quality of life, muscle mass development (BMI, skinfold and circumferences \[waist, arm, and calf area\]), patient-reported dietary intake, and exercise adherence and progression.

Вмешательства

  • Поведенческое RISE-YA Intervention
    Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.
  • Поведенческое Survivorship Education
    During weeks 1-6 and 1 time a week during Weeks 7-12, participants will receive a video call which will last about 60 minutes.

Первичные конечные точки

  • Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]

Критерии участия

Критерии включения

  • Is currently between the ages of 18-39 years
  • Their primary brain tumor was diagnosed at age 15-39 years
  • Is 6 months to <5 years post curative treatment
  • Has been treated with chemotherapy and radiation, given most patients receive both therapies.
  • Functional Assessment of Chronic Illness therapy (FACIT)-Fatigue ≤ 43. FACIT-Fatigue will be used as a screener because this 13-item scale can be completed relatively quickly in clinic
  • Currently engage in <150 minutes of PA and < 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire)
  • Must be able to speak, write, and read English
  • No exercise contraindication as assessed by screening with the Physical Activity Readiness Questionnaire PAR-Q+. In addition, participants' care teams will be notified of their participation in the study.
  • Must be able to provide informed consent/assent.

Критерии исключения

  • Non-English speaking
  • Screen failure for exercise safety
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
  • History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
  • Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
  • Self-report of pregnancy
  • Prisoners
  • Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)

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
  • The University of Texas M. D. Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07186556 · 2025-1036 · NCI-2025-06748

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗