Evaluating the Effect of a Digital Coaching Program on Self-Efficacy and Patient Reported Outcomes of Individuals With Acute and Chronic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change in Cancer Behavior Inventory (CBI) score
研究概览
简要总结
This trial studies the effect of a digital health coaching program on self-efficacy and patient reported outcomes of patients with acute myeloid leukemia or chronic lymphocytic leukemia that is newly diagnosed. A digital health coaching program may help leukemia patients report information about their health while receiving treatment, which may lead to improvement in overall health.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effect of digital health coaching on self-efficacy among two cohorts of individuals with acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), respectively, as measured by the Cancer Behavior Inventory (CBI version [v.] 3).
SECONDARY OBJECTIVES:
I. To evaluate the relationship between self-efficacy and patient reported outcomes among individuals with and without digital health coaching, specifically:
Ia. The physiologic and psychosocial outcomes of individuals with AML and CLL as measured by the Functional Assessment of Cancer Therapy-Leukemia Questionnaire (FACT-Leu).
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 read, speak and consent in English
- •Individuals newly diagnosed with either acute myelogenous (AML) or chronic lymphocytic leukemia (CLL), defined as within three months of diagnosis
- •Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments
- •Individuals with a prior history of myelodysplastic syndrome (MDS) will be allowed to enroll
排除标准
- •Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
- •Individuals who have undergone treatment for previous diagnoses of leukemia
- •Individuals for whom there is documentation of inability to provide consent in the medical record
结局指标
主要结局
Change in Cancer Behavior Inventory (CBI) score
时间窗: Baseline to 3 months
The Cancer Behavior Inventory (CBI) is 27-item instrument that measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 7-point response scale ranging from 1 "Not at all confident" to 7 "Confident" (higher score equals greater efficacy for coping). * Minimum Score-27, max- 189 * Will be calculated along with 95% confidence intervals.
次要结局
- Symptom experience(Up to 3 months)
- Perceived financial toxicity(Up to 3 months)
- Physiologic and psychosocial outcomes(Up to 3 months)