Living Well With Lymphoma

NCT06047626 | Recruiting

• 2 other identifiers: UMCC 2023.015HUM00230256
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  3 months after enrollment

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

  3 months after enrollment

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

  3 months after enrollment

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

  3 months after enrollment

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

  3 months after enrollment

Study Arms (2)

Fatigue Reduction Diet- FRD

EXPERIMENTAL

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

General Health Curriculum- GHC

ACTIVE COMPARATOR

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

Interventions

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.

Fatigue Reduction Diet- FRD

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.

General Health Curriculum- GHC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• American Institute for Cancer Research: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzie Zick

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Snyder

CONTACT

734-998-7124; fammed-szickstudy@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: September 21, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)