The Effect of an Inter-Disciplinary Program, Including Mindfulness-Based Stress Reduction, on Psychosocial Function, Pain Perception, Disability and Quality of Life in Breast Cancer Survivors With Chronic Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
研究概览
简要总结
Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.
详细描述
The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.
The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.
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 (Care Provider, Outcomes Assessor)
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
- •18 years or older.
- •Completed treatment for breast cancer a minimum of 1 year prior to study enrollment.
- •Have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months.
- •Report pain intensity levels ≥4 (moderate to severe).
排除标准
- •Metastatic disease or current evidence of cancer recurrence
- •Pregnancy or breastfeeding
- •Unable to complete questionnaires in English or French.
研究组 & 干预措施
Interdisciplinary program including MBSR
Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) program following medical treatment optimization. The MBSR program will be composed of eight weekly 2.5 hour sessions and one 6 hour session midway through the course.
干预措施: Mindfulness-Based Stress Reduction (Behavioral)
Wait-listed Control Group
Participants assigned to this group after medical treatment optimization will act as wait-list controls for the MBSR group. They will be enrolled in the MBSR workshop 3 months after the corresponding intervention group completes the program.
结局指标
主要结局
Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
时间窗: Baseline and 3 months post-intervention
The primary outcome is pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale. The Brief Pain Inventory (BPI) - Pain Interference consists of 7 numerical scales (0 to 10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.
次要结局
- Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from pre-intervention in neuronal health, as measured by white matter integrity, at 2 weeks post-intervention.(Pre-intervention and 2 weeks post-intervention)
- Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from baseline in neuropathic pain intensity, as measured by the Neuropathic Pain Symptom Inventory, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Change from baseline in immune function, as measured by blood levels of interleukin-4, interleukin-6, interleukin-10, tumor necrosis factor - alpha, and C reactive protein, at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Change from baseline in biomarkers of stress, as measured by telomere length, at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Change from pre-intervention in brain structure, as measured by changes in structural volume different areas of the brain, at 2 weeks post-intervention.(Pre-intervention and 2 weeks post-intervention)
- Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention.(Pre-intervention and 3 months post-intervention)
- Change from pre-intervention in brain areas associated with emotional regulation, as measured by blood flow in the brain seen in functional magnetic imaging, at 2 weeks post-intervention.(Pre-intervention and 2 weeks post-intervention)
- Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention(Baseline and 3 months post-intervention)
- Change from baseline in quality of life, as measured by the Short-Form-12 Health Survey, at 3 months post-intervention.(Baseline and 3 months post-intervention)