Living Well With Lymphoma

Lymphoma Clinical Trial

Official title:

Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047626
• Other study ID #: UMCC 2023.015
• Secondary ID: HUM00230256
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: September 2028

Study information

• Verified date: June 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Sara Snyder
• Phone: 734-998-7124
• Email: fammed-szickstudy[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 have started at or after the diagnosis of Lymphoma

• 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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Fatigue Reduction Diet
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
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	American Institute for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Fatigue Inventory	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	3 months after enrollment
Secondary	Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life	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.	3 months after enrollment
Secondary	The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance	Using the PROMIS SF v1.0- Sleep Disturb 8b survey	3 months after enrollment
Secondary	The effect of 3 months of FRD compared to an attention control GHC on persistent pain	Using the PROMIS SF v1.1- Pain Interference 8a survey	3 months after enrollment
Secondary	The effect of 3 months of FRD compared to an attention control GHC on persistent mood	Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys	3 months after enrollment
Secondary	The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function	Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys	3 months after enrollment
Secondary	Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program	Adherence measured with a food frequency questionnaire (FFQ) and food checklists.	3 months after enrollment
Secondary	Examining the acceptability of the FRD program- FRD initiation	Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation	3 months after enrollment
Secondary	Number of subjects who withdraw from study (acceptability)	Acceptability via withdrawals over the 3-month intervention phase	3 months after enrollment