Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brief Fatigue Inventory
研究概览
简要总结
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.
详细描述
26OCT2025- Overall enrollment increased to 100
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Brief Fatigue Inventory
时间窗: 3 months after enrollment
To examine the effect of 3 months of FRD compared to an attention control GHC on persistent fatigue, measured with the Brief Fatigue Inventory. The instrument consists of 9 items, each measuring fatigue on a 0-10 scale, and is calculated from the mean of completed items
次要结局
- The effect of 3 months of FRD compared to an attention control GHC on persistent mood(3 months after enrollment)
- Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program(3 months after enrollment)
- The effect of 3 months of FRD compared to an attention control GHC on persistent pain(3 months after enrollment)
- Examining the acceptability of the FRD program- FRD initiation(3 months after enrollment)
- Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life(3 months after enrollment)
- The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance(3 months after enrollment)
- The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function(3 months after enrollment)
- Number of subjects who withdraw from study (acceptability)(3 months after enrollment)