Preliminary Evaluation of an Internet-Assisted Cognitive Behavioral Intervention for Targeted Therapy Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Self-reported Fatigue Scores - Change From Baseline Per Scoring Category
研究概览
简要总结
The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy relative to usual care only in a small-scale randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •able to speak/read English
- •diagnosed with chronic phase CML
- •not have been treated for other cancer (except non-melanoma skin cancer) in the past 5 years
- •be under the care of a Moffitt Cancer Center (MCC) physician
- •be on a stable dose of the same oral TKI for >= 3 months
- •new onset or worsening of fatigue since starting TKI
- •report moderate-severe fatigue in past week (FSI average rating >= 4 of 0-10)
- •have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
排除标准
- •scheduled to discontinue their TKI under medical supervision within the next 3 months
结局指标
主要结局
Self-reported Fatigue Scores - Change From Baseline Per Scoring Category
时间窗: Baseline and at 18 weeks
Baseline versus follow-up fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) v.4, a 13-item self-report measure yielding total score with demonstrated reliability, validity, sensitivity to change and an identified Minimally Clinically Important Difference (MID). The fatigue subscale consists of 13 items asking about fatigue in the past 7 days. Items are summed to produce a score ranging from 0-52 with lower scores indicating greater fatigue. A difference of 3 points on the fatigue subscale indicates a clinically-important difference.
次要结局
- Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category(Baseline and at 18 weeks)