Clinical trial NCT06860880: Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
Official title: Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Indolent Lymphomas
Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma
Waldenstrom Macroglobulinemia
Cutaneous T Cell Lymphoma
Keywords: exercise
dietary intervention
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: CLL Society
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: The proportion of consented patients who are referred
timeFrame: Baseline
Secondary outcomes:
measure: Overall acceptability
timeFrame: Baseline and post-3 months follow-up
measure: Differences in self-reported fatigue
timeFrame: Baseline and post-3 months follow-up
measure: Differences in overall health
timeFrame: Baseline and post-3 months follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Basnight Cancer Hospital
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Christopher Jensen, MD MSCR
role: PRINCIPAL_INVESTIGATOR
References: