Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Cutaneous T Cell Lymphoma; Waldenstrom Macroglobulinemia; Indolent Lymphomas; Marginal Zone Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoma; Lymphoplasmacytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Other: Diet; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06860880

LCCC2403

Details and patient eligibility

About

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.

Full description

All subjects will be assigned to an exercise and dietary intervention program. Patients will engage in two patient-clinician consultations for exercise and nutrition. The individualized exercise plan designed based on the subject's medical history, current exercise habits, and specific needs, will include a mix of aerobic and resistance training.

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma

Other group

Description:

Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.

Treatment:

Other: Exercise

Other: Diet