Counseling program for lymphoma survivors to reduce fatigue
Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
This study is testing if a special counseling program about diet can help lymphoma survivors who are feeling very tired to feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06047626 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a three-month individualized counseling program focused on a Fatigue Reduction Diet (FRD) delivered by registered dietitians to lymphoma survivors experiencing persistent fatigue. Participants will be randomized to receive either the FRD counseling or an attention control group receiving a General Health Curriculum (GHC), with both groups having similar interaction frequency. The study aims to assess improvements in fatigue, quality of life, and related symptoms, as well as biological markers of inflammation, over a 15-month follow-up period. A total of 68 lymphoma survivors will be enrolled, accounting for potential dropouts.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with lymphoma and experience persistent fatigue attributed to their condition.
Not a fit: Patients who are medically unstable or have untreated mood disorders, anemia, or hypothyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and reduce fatigue in lymphoma survivors.
How similar studies have performed: Other studies have shown promising results with dietary interventions for cancer-related fatigue, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Suzie Zick — University of Michigan Rogel Cancer Center
- Study coordinator: Sara Snyder
- Email: fammed-szickstudy@med.umich.edu
- Phone: 734-998-7124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.