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NCT Number: NCT06047626

Living Well With Lymphoma

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Sara Snyder

CONTACT

[email protected]

734-998-7124

Suzie Zick

PRINCIPAL_INVESTIGATOR

About this study

26OCT2025- Overall enrollment increased to 100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fatigue Reduction Diet

Other

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.

General Health Curriculum

Other

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.

Primary outcomes

  1. Brief Fatigue Inventory

    Time frame: 3 months after enrollment

    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

Secondary outcomes

  1. Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life

    Time frame: 3 months after enrollment

    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.

  2. The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance

    Time frame: 3 months after enrollment

    Using the PROMIS SF v1.0- Sleep Disturb 8b survey

  3. The effect of 3 months of FRD compared to an attention control GHC on persistent pain

    Time frame: 3 months after enrollment

    Using the PROMIS SF v1.1- Pain Interference 8a survey

  4. The effect of 3 months of FRD compared to an attention control GHC on persistent mood

    Time frame: 3 months after enrollment

    Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys

  5. The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function

    Time frame: 3 months after enrollment

    Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys

  6. Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program

    Time frame: 3 months after enrollment

    Adherence measured with a food frequency questionnaire (FFQ) and food checklists.

  7. Examining the acceptability of the FRD program- FRD initiation

    Time frame: 3 months after enrollment

    Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation

  8. Number of subjects who withdraw from study (acceptability)

    Time frame: 3 months after enrollment

    Acceptability via withdrawals over the 3-month intervention phase

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Snyder

CONTACT

[email protected]

734-998-7124

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • American Institute for Cancer Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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