NCT06047626NARecruiting

Living Well With Lymphoma

University of Michigan Rogel Cancer Center

Start Date

3/7/2024

Completion Date

9/1/2028

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Interventions

OTHER

Fatigue Reduction Diet

OTHER

General Health Curriculum

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Conditions

Lymphoma

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States