Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
研究概览
简要总结
The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).
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
- Double (Participant, Investigator)
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
- •Age 18 and over
- •Able to speak and read English
- •Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years
排除标准
- •Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
- •Major psychiatric disorder (e.g., psychosis, personality disorder)
- •Current suicidal ideation or suicide attempt within past 3 months
- •Past participation in an MBCT group
研究组 & 干预措施
Mindfulness Based Cognitive Therapy (MBCT)
MBCT is a structured 8-week group intervention which integrates aspects of cognitive behavioral therapy (CBT) with components of the Mindfulness Based Stress Reduction (MBSR) program.
干预措施: Mindfulness Based Cognitive Therapy (Behavioral)
Treatment as Usual (TAU)
Subjects randomized to TAU will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study (for the TAU group) and outside of the study (for the MBCT group) will be assessed at the 3-month follow up (Visit 3).
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
时间窗: 3 Months
This measure consists of 20-items that assess trait anxiety and 20 for state anxiety.
Change in level of Depression using the Beck Depression Inventory-II (BDI-II)
时间窗: 3 Months
The 21-item version of this widely used measure will be used to assess depressive symptoms.
次要结局
- Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)(3 Months)
- Change in Rumination using the Ruminative Responses Scale (RSS):(3 Months)
- Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)(3 Months)
- Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):(3 Months)
- Change in Physical Health Symptoms(3 Months)
- Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):(3 Months)