Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
Summary
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.
Detailed description
26OCT2025- Overall enrollment increased to 100
Arms & interventions
- OtherFatigue 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 carbohydrates from non-fruit and vegetable sources; 1 serving of fatty fish and or 1 serving of nuts and/or seeds (2 servings of nuts and/or seeds for vegetarians), both the fish, the nuts, and seeds will replace existing sources of fats and proteins in the diet.
- OtherGeneral 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.
Outcome measures
Primary
Brief Fatigue Inventory
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
Time frame: 3 months after enrollment
Secondary
Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent pain
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent mood
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function
Time frame: 3 months after enrollment
Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program
Time frame: 3 months after enrollment
Examining the acceptability of the FRD program- FRD initiation
Time frame: 3 months after enrollment
Number of subjects who withdraw from study (acceptability)
Time frame: 3 months after enrollment
Eligibility criteria
Study locations (1)
University of Michigan
Ann Arbor, Michigan, 48109