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NCT06047626 | RECRUITING | Lymphoma

Living Well With Lymphoma
Sponsor:

University of Michigan Rogel Cancer Center

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.

Condition or disease

Lymphoma

Intervention/treatment

Fatigue Reduction Diet

General Health Curriculum

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 68 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
Actual Study Start Date : 2024-03-07
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2028-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Living Well With Lymphoma

Location Details

NCT06047626

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109