Living Well With Lymphoma

Not Applicable

Recruiting

• Conditions: Lymphoma
• Interventions: Other: Fatigue Reduction Diet; Other: General Health Curriculum

• Registration Number: NCT06047626
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2024-03-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fatigue Reduction Diet- FRD	Fatigue Reduction Diet	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
General Health Curriculum- GHC	General Health Curriculum	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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 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
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 sleep disturbance	3 months after enrollment	Using the PROMIS SF v1.0- Sleep Disturb 8b survey
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
Number of subjects who withdraw from study (acceptability)	3 months after enrollment	Acceptability via withdrawals over the 3-month intervention phase

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States