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Living Well With Lymphoma

Primary Purpose

Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fatigue Reduction Diet
General Health Curriculum
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Women and men aged 18 years and older Diagnosis of DLBCL treated with R-CHOP or R-EPOCH Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory Fatigue must have started at or after the diagnosis of DLBCL Completed all primary cancer treatments (e.g., chemotherapy) between 6 months to 2 years prior Have no evidence of DLBCL disease progression 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 or >35 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fatigue Reduction Diet- FRD

    General Health Curriculum- GHC

    Arm Description

    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

    3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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
    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
    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
    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
    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.
    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
    Number of subjects who withdraw from study (acceptability)
    Acceptability via withdrawals over the 3-month intervention phase

    Full Information

    First Posted
    April 3, 2023
    Last Updated
    September 14, 2023
    Sponsor
    University of Michigan Rogel Cancer Center
    Collaborators
    American Institute for Cancer Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06047626
    Brief Title
    Living Well With Lymphoma
    Official Title
    Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    January 2027 (Anticipated)
    Study Completion Date
    January 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Michigan Rogel Cancer Center
    Collaborators
    American Institute for Cancer Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fatigue Reduction Diet- FRD
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    General Health Curriculum- GHC
    Arm Type
    Active Comparator
    Arm Description
    3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC)
    Intervention Type
    Other
    Intervention Name(s)
    Fatigue Reduction Diet
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    General Health Curriculum
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Brief Fatigue Inventory
    Description
    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
    Time Frame
    3 months after enrollment
    Secondary Outcome Measure Information:
    Title
    Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life
    Description
    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.
    Time Frame
    3 months after enrollment
    Title
    The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance
    Description
    Using the PROMIS SF v1.0- Sleep Disturb 8b survey
    Time Frame
    3 months after enrollment
    Title
    The effect of 3 months of FRD compared to an attention control GHC on persistent pain
    Description
    Using the PROMIS SF v1.1- Pain Interference 8a survey
    Time Frame
    3 months after enrollment
    Title
    The effect of 3 months of FRD compared to an attention control GHC on persistent mood
    Description
    Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys
    Time Frame
    3 months after enrollment
    Title
    The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function
    Description
    Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys
    Time Frame
    3 months after enrollment
    Title
    Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program
    Description
    Adherence measured with a food frequency questionnaire (FFQ) and food checklists.
    Time Frame
    3 months after enrollment
    Title
    Examining the acceptability of the FRD program- FRD initiation
    Description
    Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation
    Time Frame
    3 months after enrollment
    Title
    Number of subjects who withdraw from study (acceptability)
    Description
    Acceptability via withdrawals over the 3-month intervention phase
    Time Frame
    3 months after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women and men aged 18 years and older Diagnosis of DLBCL treated with R-CHOP or R-EPOCH Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory Fatigue must have started at or after the diagnosis of DLBCL Completed all primary cancer treatments (e.g., chemotherapy) between 6 months to 2 years prior Have no evidence of DLBCL disease progression 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 or >35 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Snyder
    Phone
    734-998-7124
    Email
    fammed-szickstudy@med.umich.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzie Zick
    Organizational Affiliation
    University of Michigan Rogel Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No we would not make individual data just composite data available.

    Learn more about this trial

    Living Well With Lymphoma

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