Lymphoma
Conditions
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.
Detailed description
26OCT2025- Overall enrollment increased to 100
Interventions
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.
OTHERGeneral Health Curriculum
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.
Sponsors
American Institute for Cancer Research
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory | 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
| Measure | Time frame | Description |
|---|---|---|
| The effect of 3 months of FRD compared to an attention control GHC on persistent mood | 3 months after enrollment | Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys |
| The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance | 3 months after enrollment | Using the PROMIS SF v1.0- Sleep Disturb 8b survey |
| Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life | 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. |
| The effect of 3 months of FRD compared to an attention control GHC on persistent pain | 3 months after enrollment | Using the PROMIS SF v1.1- Pain Interference 8a survey |
| Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program | 3 months after enrollment | Adherence measured with a food frequency questionnaire (FFQ) and food checklists. |
| Examining the acceptability of the FRD program- FRD initiation | 3 months after enrollment | Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation |
| Number of subjects who withdraw from study (acceptability) | 3 months after enrollment | Acceptability via withdrawals over the 3-month intervention phase |
| The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function | 3 months after enrollment | Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys |
Countries
United States
Contacts
Primary ContactSara Snyder
Outcome results
None listed