Living Well With Lymphoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Other: Fatigue Reduction Diet
* Other: General Health Curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men aged 18 years and older Diagnosis of DLBCL treated with R-CHOP or R-EPOCH Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory Fatigue must have started at or after the diagnosis of DLBCL Completed all primary cancer treatments (e.g., chemotherapy) between 6 months to 2 years prior Have no evidence of DLBCL disease progression Fruit and vegetable intake ≤5.5 servings/day Have, or be willing to create, an email address to receive study questionnaires electronically. Exclusion Criteria: Medically unstable BMI<18.5 or >35 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatigue Reduction Diet- FRD<br>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 | Other: Fatigue Reduction Diet<br>* 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.<br>|
| Active Comparator: General Health Curriculum- GHC<br>3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC) | Other: General Health Curriculum<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life | Quality of life, using the Functional Assessment of Chronic Illness Therapy Measurement System, specifically the lymphoma cancer specific instrument. The total score will be our primary outcome. The FACT-G has demonstrated reliability, validity, and responsiveness to change over time. | 3 months after enrollment | 
| The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance | Using the PROMIS SF v1.0- Sleep Disturb 8b survey | 3 months after enrollment | 
| The effect of 3 months of FRD compared to an attention control GHC on persistent pain | Using the PROMIS SF v1.1- Pain Interference 8a survey | 3 months after enrollment | 
| The effect of 3 months of FRD compared to an attention control GHC on persistent mood | Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys | 3 months after enrollment | 
| The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function | Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys | 3 months after enrollment | 
| Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program | Adherence measured with a food frequency questionnaire (FFQ) and food checklists. | 3 months after enrollment | 
| Examining the acceptability of the FRD program- FRD initiation | Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation | 3 months after enrollment | 
| Number of subjects who withdraw from study (acceptability) | Acceptability via withdrawals over the 3-month intervention phase | 3 months after enrollment |