NCT04072406终止不适用
A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be ≥ 18 years old
- •Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other)
- •Be native English speakers
- •Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment;
- •Not currently be practicing weekly meditation
- •Be willing to create (or already have) an email address
- •Have access to internet via a personal electronic device (or be willing to borrow an internet-enabled tablet from the study team).
排除标准
- •<18 years old
- •Distress Thermometer ratings ≤ 3
- •Non-native English speakers
- •Individuals with severe depression, and individuals who are having suicidal thoughts.
- •Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already)
- •Individuals who are currently practicing weekly meditation
- •Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol IRB#: 201511102 (chemoresistance) or IRB# 201804169 (Cytokine-induced depression).
结局指标
主要结局
Change in symptoms of anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
时间窗: From Baseline to week 3
-On the 14-item Hospital Anxiety and Depression Scale (HADS) symptoms of anxiety (7) and depression (7) are rated on a scale from 0 (less severe) to 3 (more severe).
次要结局
- Change in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)(From Baseline to week 3)
- Change in symptoms of distress as measured by the National Comprehensive Cancer Network Distress Thermometer(From Baseline to week 3)
- Change in symptoms of depression as measured by the Hospital Anxiety and Depression Scale (HADS)(From Baseline to week 3)
- Change in overall physical symptoms as measured by the Edmonton Symptoms Associated Scale Revised(From Baseline to week 3)
- Change in emotion regulation as measured by the Emotion Regulation Questionnaire(From Baseline to week 3)
- Change in perceived stress as measured by the Perceived Stress Scale(From Baseline to week 3)
- Change in coping as measured by the Cognitive Emotion Regulation Questionnaire(From Baseline to week 3)
- Change in mindfulness as measured by the Five-Facet Mindfulness Questionnaire(From Baseline to week 3)
- Change in self-compassion as measured by the Sussex-Oxford Compassion for Self Scale(From Baseline to week 3)
研究者
研究点 (2)
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