Clinical trial NCT06047626: Living Well With Lymphoma
Official title: Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: American Institute for Cancer Research
First posted: 2023-09-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Brief Fatigue Inventory
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life
timeFrame: 3 months after enrollment
measure: The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance
timeFrame: 3 months after enrollment
measure: The effect of 3 months of FRD compared to an attention control GHC on persistent pain
timeFrame: 3 months after enrollment
measure: The effect of 3 months of FRD compared to an attention control GHC on persistent mood
timeFrame: 3 months after enrollment
measure: The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function
timeFrame: 3 months after enrollment
measure: Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program
timeFrame: 3 months after enrollment
measure: Examining the acceptability of the FRD program- FRD initiation
timeFrame: 3 months after enrollment
measure: Number of subjects who withdraw from study (acceptability)
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Suzie Zick
role: PRINCIPAL_INVESTIGATOR
References: