Living Well With Lymphoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06047626
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 7, 2024
Status verified
Oct 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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
  • 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)

Primary Outcome Measure

Brief Fatigue Inventory [ Time Frame: 3 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Sara Snyder
[email protected]
734-998-7124
Suzie Zick (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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