Combating Cancer-Related Fatigue: A Personalized Supportive Care Program

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• The proportion of consented patients who are referred [Срок оценки: Baseline]

Вторичные конечные точки (3)

• Overall acceptability [Срок оценки: Baseline and post-3 months follow-up]
• Differences in self-reported fatigue [Срок оценки: Baseline and post-3 months follow-up]
• Differences in overall health [Срок оценки: Baseline and post-3 months follow-up]

Критерии участия

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

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• North Carolina Basnight Cancer Hospital — Chapel Hill

Идентификаторы

NCT: NCT06860880 · LCCC2403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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