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HEALTH4CLL2：慢性淋巴细胞白血病患者行为干预的随机候补对照试验

2026年9月17日 更新者：M.D. Anderson Cancer Center

To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Primary Objective:

--Evaluate the impact of an organized, longitudinal, diet and exercise training program on fatigue as assessed by the Functional Assessment of Cancer Therapy (FACT) score in patients with CLL.

Secondary Objectives:

--Assess changes in physical activity, dietary behavior, physical function using the PROMIS physical function questionnaire and performance tests of physical function, body mass index (BMI) and global quality of life. Additionally, we will assess changes in fecal microbiome composition, metabolic parameters including a comprehensive lipid panel, glucose, insulin, TNF alpha, IL6, leptin, resistin, adiponectin, IGF1 and IGFBP1 and immunologic function as assessed by T cell and monocyte phenotypic and functional assays in patients with CLL after participation in the behavioral intervention.

Exploratory Objectives:

-- Identify differences in the metabolic, immunologic and fecal microbiome composition in patients with CLL who have a high CLL comorbidity index score (CLL-CI) compared to patients with CLL and a low CLL-CI score. And, investigate the association of comorbidity score, disease features, CLL-specific prognostic factors and clinical outcomes.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Texas
      • Houston、Texas、美国、77030
        • M D Anderson Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults age 18-85 years of age with a histologically confirmed diagnosis of CLL and the ability to provide signed informed consent.
  • Self-reported physical activity will be assessed prior to enrollment and patients with a physical activity level below the level prescribed in our study will be eligible for inclusion.

Exclusion Criteria:

  • Other active malignancy within 1 year of study enrollment (excluding non-melanoma skin cancer)
  • Richter's transformation, another medical condition which would prevent safe participation in the behavioral intervention
  • Major surgery within 1 month of enrollment
  • Non-English speakers
  • Cognitively impaired adults
  • Pregnancy.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1 (Behavioral)

Participants are randomly assigned a study group, pariticipants will be given the following:

  • A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale.
  • Resistance bands with an instructional video on how to use them.
  • Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.
行为的：Questionnaires

Survey

其他：Fit Bit

measures physical activity
实验性的：Group 2 (Waitlist)

Participants are randomly assigned a study group, pariticipants will be given the following:

  • A Fitbit to wear every day during the study. A Fitbit is a physical activity tracking device that will help measure your physical activity. Participants will also receive a Fitbit Aria weight scale. Participants need to create a Fitbit account on the Fitbit website, which will allow participants to track your physical activity and log your diet information and weight. A member of the study team will call you or help you in-person (if you are in the clinic) to help set up the Fitbit and scale.
  • Resistance bands with an instructional video on how to use them.
  • Educational materials, such as handouts about diabetes prevention, as well as written/verbal/video instructions on setting up the Fitbit and scale. This will also include information about online safety/privacy.
行为的：Questionnaires

Survey

其他：Fit Bit

measures physical activity

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Functional Assessment of Cancer Therapy (FACT) questionnaires.
大体时间：through study completion; an average of 1 year.

Score Scale ranges (0-4)

0-Not at all

1-A little bit

3-Somewhat

4-Quite a bit

5-Very much
through study completion; an average of 1 year.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

M.D. Anderson Cancer Center

合作者

CLL Global Research Foundation

调查人员

  • 首席研究员：Alessandra Ferrajoli, MD、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月17日

初级完成 (估计的)

2027年7月3日

研究完成 (估计的)

2027年7月3日

研究注册日期

首次提交

2023年5月18日

首先提交符合 QC 标准的

2023年5月18日

首次发布 (实际的)

2023年5月30日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2022-0411
  • NCI-2023-04161 (其他标识符：NCI-Clinical Trials Registry)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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