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临床试验/NCT01228461
NCT01228461已完成不适用

Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Prevalence and severity of fatigue and its impact on functional outcomes

研究概览

简要总结

Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk.

The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following:

Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue

Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors.

Hypotheses:

  1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.
  2. Risk factors for fatigue include higher disease stage, B symptoms and elevated erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher doses and more expanded fields of radiotherapy.
  3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
  4. Levels of specified proinflammatory cytokines are associated with increased fatigue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 39 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Currently 18 years of age or older
  • Alive without evidence of recurrent disease
  • Must be off therapy (not on active treatment for HL or other malignancies)
  • Must not be on any form of chemotherapy (oral or intravenous [IV])
  • Provide informed consent
  • Can read and understand English
  • Treated with risk-adapted therapy which may include radiotherapy doses < 30 Gy

排除标准

  • Evidence of a subsequent malignancy following lymphoma treatment

结局指标

主要结局

Prevalence and severity of fatigue and its impact on functional outcomes

时间窗: 1 year

次要结局

  • Evaluate the association between levels of proinflammatory cytokine activity and fatigue(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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