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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00230256 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| American Institute for Cancer Research | OTHER |
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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.
26OCT2025- Overall enrollment increased to 100
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fatigue Reduction Diet- FRD | Experimental | 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 |
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| General Health Curriculum- GHC | Active Comparator | 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fatigue Reduction Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Snyder | Contact | 734-998-7124 | fammed-szickstudy@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suzie Zick | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
No we would not make individual data just composite data available.
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| General Health Curriculum | Other | 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. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of subjects who withdraw from study (acceptability) | Acceptability via withdrawals over the 3-month intervention phase | 3 months after enrollment |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |