Treatment for Breast and Colorectal Cancer Survivors With Persistent Cancer-Related Fatigue: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 8
- 主要终点
- Change in cancer-related fatigue functional interference
研究概览
简要总结
The purpose of this study is to compare the effects of Mindfulness-Based Stress Reduction (MBSR) to an attention control psycho-educational support group in treating cancer-related fatigue (CRF) in early-stage (0-III) post-treatment cancer survivors with clinically-significant CRF. The study will collect, store, and later analyze blood and urine samples for several biomarkers that may be linked to persistent CRF in cancer survivors.
详细描述
This is a randomized, attention control clinical trial to compare MBSR to support and education on biobehavioral outcomes in early-stage (0-III) post-treatment cancer survivors with clinically-significant CRF. The study will use quantitative and qualitative methods to evaluate the following:
Primary Aim 1: Determine effect size estimates of MBSR compared to attention control in reducing fatigue interference and the severity of several cancer-related symptoms immediately post-intervention and at 6-month follow-up.
Exploratory Aim 1: To identify potential moderators of intervention effects in breast cancer survivors (BCS) and colorectal cancer survivors (CRCS), such as demographic, clinical/disease characteristics, personality traits, and baseline mindfulness level.
Exploratory Aim 2: To compare levels of a number of anti- and pro-inflammatory proteins present in blood and urine between MBSR and attention control groups immediately post-intervention and 6-month follow-up, and between fatigued and non-fatigued breast cancer survivors at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in cancer-related fatigue functional interference
时间窗: from baseline to 6 month follow-up
The Fatigue Symptom Inventory interference subscale will be used to assess the degree to which CRF was judged to interfere with quality of life across seven domains over the previous week.
次要结局
- Change in fear of recurrence(from baseline to 6 month follow-up)
- Change in cancer-related fatigue severity(from baseline to 6 month follow-up)
- Change in vitality(from baseline to 6 month follow-up)
- Change in depression(from baseline to 6 month follow-up)
- Change in attentional function(from baseline to 6 month follow-up)
- Change in anxiety(from baseline to 6 month follow-up)
- Change in sleep disturbance(from baseline to 6 month follow-up)
- Change in pain(from baseline to 6 month follow-up)
研究者
Shelley Johns
Assistant Professor of Medicine
Indiana University