Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
NCT ID: NCT06860880
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-03
2026-12-31
Brief Summary
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Detailed Description
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Concurrently, participants will receive nutritional consultations from a specialized oncology dietitian. These sessions will focus on creating a diet plan tailored to each participant's nutritional needs, considering their treatment and overall health. Study participants will complete weekly exercise journals to track adherence to the exercise prescription and complete weekly assessments of their adherence to dietary recommendations on an integer scale ranging from 0-10.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CLL Society
UNKNOWN
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christopher Jensen, MD MSCR
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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North Carolina Basnight Cancer Hospital
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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UNC Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2403
Identifier Type: -
Identifier Source: org_study_id
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