The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Self-reported Change in Pain-related Disability
研究概览
简要总结
In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with primary breast cancer
- •Unilateral surgery including, either:
- •Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery
排除标准
- •Active metastasis
- •Cannot participate during the entire study period
研究组 & 干预措施
Intervention group
Standard physical therapy program + Modern educational program
干预措施: Standard physical therapy program (Other)
Intervention group
Standard physical therapy program + Modern educational program
干预措施: Modern educational program (Other)
Control group
Standard physical therapy program + Traditional biomedical educational program
干预措施: Standard physical therapy program (Other)
Control group
Standard physical therapy program + Traditional biomedical educational program
干预措施: Traditional biomedical educational program (Other)
结局指标
主要结局
Self-reported Change in Pain-related Disability
时间窗: Change between baseline and one year follow-up assessment
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
次要结局
- Self-reported Pain-related Disability(Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up))
- Self-reported Pain-intensity(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Central Sensitization Symptoms(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Altered Somatosensory Functions (Touch)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Altered Somatosensory Functions (Temperature-warmth)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Upper Limb Function(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- General Physical Activity Level(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment))
- Self-reported Emotional Functioning: Pain Catastrophizing(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Emotional Functioning: Depression(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Health-related Quality of Life(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Socio-economic Outcomes: Return to Work Rate(Postoperatively after 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Altered Somatosensory Functions (Temperature-cold)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Altered Somatosensory Functions (Nociception: Pinprick Sensation)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity)(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Emotional Functioning: Anxiety(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))
- Self-reported Emotional Functioning: Stress(Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up))