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NCT06860880 | NOT YET RECRUITING | Indolent Lymphomas

Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
Sponsor:

UNC Lineberger Comprehensive Cancer Center

Brief Summary:

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.

Condition or disease

Indolent Lymphomas

Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Lymphoplasmacytic Lymphoma

Waldenstrom Macroglobulinemia

Cutaneous T Cell Lymphoma

Intervention/treatment

Exercise

Diet

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

    Location Details

    NCT06860880

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, North Carolina

    North Carolina Basnight Cancer Hospital

    Chapel Hill, North Carolina, United States, 27514