Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06860880
• Lead 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.

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 Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The proportion of consented patients who are referred	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.

Secondary Outcome Measures

Name	Time	Method
Overall acceptability	Baseline and post-3 months follow-up	Overall acceptability will be measured as the proportion of participants who report being "Neutral," "Satisfied" or "Very Satisfied" with the intervention utilizing the Cancer Fatigue Program Participant Feedback Questionnaire- Part 1. The questionnaire has 2 parts and the first part has 8 multiple choice questions. Options are very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
Differences in self-reported fatigue	Baseline and post-3 months follow-up	Differences in self-reported fatigue will be determined by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (PROMIS Item Bank v1.0 Fatigue Short Form13a (FACIT-Fatigue)) questionnaire. It uses a scoring system to assess the severity of fatigue and its impact on daily activities. There are 13 items and each item in the short form has five response options, typically ranging from 1 (not at all) to 5 (very much), the lowest possible raw score is 13, and the highest possible raw score is 65.
Differences in overall health	Baseline and post-3 months follow-up	Differences in overall health will be determined by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health (PROMIS Scale v1.2 Global Health) scores. The PROMIS Scale v1.2 Global Health measures both physical and mental health through a set of items. Each item has five response options, typically ranging from 1 (poor) to 5 (excellent). Higher Scores: Indicate better health and lower Scores: Indicate poorer health.

Trial Locations

Locations (1)

North Carolina Basnight Cancer Hospital; 🇺🇸 Chapel Hill, North Carolina, United States