The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients: a Mechanistic Study of Art Therapy in Reducing Depression, Fatigue and Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.
详细描述
The study is a randomized controlled study with careful controls. Our study population is comprised of 240 BC patients in palliative and curative care (comprised of 50% Jewish and 50% Arab). This population will be randomized to receive a standard art therapy intervention or a comparison group. The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist The comparison group will engage in the coloring of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping with BC, identical to the topics of the AT group. This design will allow the study to test the mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement with art materials.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The control group is designed to be similar to the intervention, participants will be engaged in interacting with art materials. Research assistants will be blinded to group allocation when collecting data.
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
- •adult (>18) females with initial or recurrent BC
- •intervention can begin 3 months after finishing chemotherapy and radiotherapy (RT) and one month after surgery, up until 18 months after treatment completion.
- •can complete assessments in Arabic or Hebrew
- •provides informed consent.
排除标准
- •lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or with a pre- cancer diagnosis of fibromyalgia or chronic fatigue syndrome
- •active suicidal plan (will ensure immediate intervention);
- •dementia/other disorder that would preclude informed consent or comprehension of assessments
- •Individuals taking anticholinergic medications, and post myocardial infarction (6 months before recruitment) or with a pacemaker, which would render the metric of HRV invalid.
- •Flare-up in systemic autoimmune disease (such as arthritis, lupus or multiple sclerosis), thyroid dysfunction that requires increases in medication
结局指标
主要结局
Fatigue
时间窗: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Fatigue will be assessed using the Fatigue Symptom Inventory (FSI), a 14-item self-report measure designed to assess the severity of fatigue on an 11-point scale (0=not at all fatigued; 10=as fatigued as I could be) that assesses most, least, and average fatigue in the past week. A global score can be obtained summing items 1-13, resulting in a scale with a range between 0-130. Higher results represent higher levels of global fatigue.
Pain (Impact and Interference)
时间窗: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the PROMIS Pain Interference Scale measures how much pain interfered with different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or interference with functioning. Our data indicates t-scores calculated so that 50 indicates the population (cancer patient) mean with a standard deviation of 10.
Depression Depression
时间窗: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology.
次要结局
- Emotional Expression(Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3))
- Inflammation(Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).)
- Heart Rate Variability(Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3))
- Emotional Awareness(Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3))
- Acceptance of Emotions(Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3))
研究者
Johanna Czamanski-Cohen
Principal Investigator
University of Haifa