Living Well With Lymphoma

Purpose

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.

Condition

  • Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fatigue Reduction Diet- FRD 		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
    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.
Active Comparator
General Health Curriculum- GHC 		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
    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.

Recruiting Locations

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Sara Snyder
734-998-7124
fammed-szickstudy@med.umich.edu

More Details

NCT ID
NCT06047626
Status
Recruiting
Sponsor
University of Michigan Rogel Cancer Center

Study Contact

Sara Snyder
734-998-7124
fammed-szickstudy@med.umich.edu

Detailed Description

26OCT2025- Overall enrollment increased to 100

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center