Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of consented patients who are referred
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.
干预措施: Exercise (Other)
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma
Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs.
干预措施: Diet (Other)
结局指标
主要结局
The proportion of consented patients who are referred
时间窗: 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.
次要结局
- Overall acceptability(Baseline and post-3 months follow-up)
- Differences in self-reported fatigue(Baseline and post-3 months follow-up)
- Differences in overall health(Baseline and post-3 months follow-up)