Living Well With Lymphoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Other: Fatigue Reduction Diet; Other: General Health Curriculum

Detailed Description

26OCT2025- Overall enrollment increased to 100

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Snyder; Phone Number: 734-998-7124; Email: fammed-szickstudy@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Sara Snyder; Phone Number: 734-998-7124; Email: fammed-szickstudy@med.umich.edu
      • Principal Investigator: Suzie Zick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: American Institute for Cancer Research
• Investigators: Principal Investigator: Suzie Zick, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma
• Other Study ID Numbers: UMCC 2023.015; HUM00230256 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No we would not make individual data just composite data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No