Living Well With Lymphoma

Официальное название

Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life

Обзор

In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.

Подробное описание

26OCT2025- Overall enrollment increased to 100

Вмешательства

• Другое Fatigue Reduction Diet
  Sessions will be \~15 minutes for 8 sessions. The FRD maintains participants on a diet with their typical caloric intake as assessed at baseline, and replaces some of their calories with the following foods on a daily basis: at least 50% of servings grains to be whole grains (these would replace non-whole grain foods); 5 servings of vegetables (1 leafy green, 1 tomato, and 1 yellow/orange); 2 servings of fruit (1 high in vitamin C), both fruit and vegetables would replace some of the carbohydrat
• Другое General Health Curriculum
  These sessions will be matched counseling method, time spent (\~15 minutes per session), for 8 sessions. Registered Dietitians will discuss general health topics with the participant, excluding topics of diet and food.

Первичные конечные точки

• Brief Fatigue Inventory [Срок оценки: 3 months after enrollment]

Вторичные конечные точки (8)

• Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life [Срок оценки: 3 months after enrollment]
• The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance [Срок оценки: 3 months after enrollment]
• The effect of 3 months of FRD compared to an attention control GHC on persistent pain [Срок оценки: 3 months after enrollment]
• The effect of 3 months of FRD compared to an attention control GHC on persistent mood [Срок оценки: 3 months after enrollment]
• The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function [Срок оценки: 3 months after enrollment]
• Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program [Срок оценки: 3 months after enrollment]
• Examining the acceptability of the FRD program- FRD initiation [Срок оценки: 3 months after enrollment]
• Number of subjects who withdraw from study (acceptability) [Срок оценки: 3 months after enrollment]

Критерии участия

Критерии включения

• Women and men aged 18 years and older
• Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
• Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
• Fatigue must be attributed to lymphoma diagnosis
• Fatigue onset must be between 12months before diagnosis and any time after diagnosis
• Fatigue must not be attributed to other disease diagnoses
• Fruit and vegetable intake ≤5.5 servings/day
• Have, or be willing to create, an email address to receive study questionnaires electronically.

Критерии исключения

• Medically unstable
• BMI<18.5 kg/m2
• Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
• Have a current untreated diagnosis of anemia
• Have a current untreated diagnosis of hypothyroidism
• Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study
• Have a current diagnoses of cachexia
• Planning on becoming pregnant, currently pregnant or lactating

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

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06047626 · UMCC 2023.015 · HUM00230256

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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