Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Post-surgical fatigue
研究概览
简要总结
The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.
详细描述
The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with breast cancer and scheduled for surgery
- •Be able to provide informed consent
排除标准
- •Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
- •Cognitive and psychiatric impairment
- •Other serious malignancies
结局指标
主要结局
Post-surgical fatigue
时间窗: 3 months after surgery
Measured through the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) which is a unidimensional self-report scale to assess fatigue and its impact on daily life. The score range is 0-52 where a higher score indicates better quality of life (i.e. less symptoms and disability)
Chronic post-surgical pain
时间窗: 3 months after surgery
Measured through a Numeric Rating Scale (NRS) for pain intensity. The scale ranges from 0-10, anchored by verbal descriptors at either end of the scale where 0 is no pain at all and 10 is the worst possible pain.
次要结局
- Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset(On the day of surgery right before discharge)
- Number of psychotropic and pain-related prescriptions(3 and 12 months post-surgery)
- Stress (immunological) reactivity(Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline))
- Number of sick leave days(3 and 12 months post-surgery)
- Psychological flexibility(3 and 12 months post-surgery)
- Psychological distress(3 and 12 months post-surgery)
研究者
Silje Endresen Reme
Professor
University of Oslo