NCT06860880 · UNC Lineberger Comprehensive Cancer Center
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
What this study is about
This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas.
View original scientific description
This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.
Interventions
OTHER
Exercise
Each patient will receive an individualized exercise prescription that will encompass both aerobic and resistance training, with modifications as necessary to accommodate each patient's needs, abilities, and medical condition. For those not participating in any formal exercise at baseline, the exercise prescription will consist of a basic conditioning program targeting 150 minutes of moderate physical activity weekly with the assistance of a physical therapist if deemed appropriate.
OTHER
Diet
Participants will undergo nutritional consultations with a registered dietitian who specializes in oncology. The dietitian will provide tailored dietary recommendations using evidence-based nutrition guidelines. Participants will also be screened ffor ormal nutrition based on American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines as indicated.
Primary outcome measures
The proportion of consented patients who are referred
Time frame: Baseline
The proportion of consented patients with chronic lymphocytic leukemia (CLL) or other forms of indolent lymphoma who are referred to cancer rehabilitation and dietician and attend an initial appointment with each.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.
- Significant symptoms of fatigue, as defined by PROMIS Fatigue score \>50.
Exclusion criteria
- Other co-existing malignancies.
- Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.
- Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.
- Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention
Where
- Chapel Hill, North Carolina
Collaborators
CLL Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations