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Идёт набор NCT05839210

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

Без фазы С лечением Non Hodgkin Lymphoma 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
В протоколе указаны: LIFE-L Mediterranean Diet, LIFE-L Home-Based Exercise Program, Supportive Materials.
Кому может быть актуально
Состояния в реестре: Non Hodgkin Lymphoma, Hodgkin Lymphoma. 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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Официальное название

Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)

Обзор

The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.

Вмешательства

  • Поведенческое LIFE-L Mediterranean Diet
    Mediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol.
  • Поведенческое LIFE-L Home-Based Exercise Program
    The Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week.
  • Поведенческое Supportive Materials
    Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be

Первичные конечные точки

  • Percentage of Survivors who participate [Срок оценки: Up to 12 months]
  • Percentage of Participants Completing Intervention Sessions [Срок оценки: Up to 26 weeks (Post-Intervention)]
  • Change in percentage of participant satisfaction [Срок оценки: 4 weeks (post-intervention), up to 30 weeks]
Вторичные конечные точки (1)
  • Average Relative Dose Intensity (RDI) [Срок оценки: Up to 30 weeks]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Any sex/gender
  • Able to provide consent
  • Able to read or understand English or Spanish
  • Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
  • R-CHOP or R-CHOP-like regimen
  • BR
  • BV-AVD or ABVD or checkpoint inhibitor+AVD
  • ECOG Performance Status grade of <2

a. PI approval needed if ECOG = 2

  • Approval from treating oncologist, confirmed via email or in writing
  • Delivery of chemotherapy treatments at one of the following institutions:
  • Sylvester Comprehensive Cancer Center (including satellite/network sites)
  • University of Miami Hospital/UHealth Tower
  • Internet access on a smart phone, tablet, or computer
  • Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Критерии исключения

  • Individuals younger than 18 years of age
  • Unable to provide consent
  • Unable to read or understand English or Spanish
  • Any contraindication for diet change or exercising as determined by physician
  • Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
  • Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
  • History of dementia or major psychiatric disease
  • History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

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
Другое

Центры проведения

США · 1 центр
  • University of Miami — Miami

Идентификаторы

NCT: NCT05839210 · 20221298

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗