Supportive Effects of Craniosacral Therapy for Women With Breast Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Breast cancer-related quality of life - total score
研究概览
简要总结
Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept.
Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered self-selection to either individual CST or CST self-help group training. For all groups, treatment as usual is allowed.
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 (Investigator, Outcomes Assessor)
盲法说明
The investigator who will perform the group assignment will have no contact to the study participants. The outcome assessors will be blinded to group allocation. The statistician who will perform the analyses will kept blind to the group intervention by renaming groups with numbers.
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
- •Breast cancer (stage I-III) survivors after finishing curative chemotherapy and/or radiation
- •Impaired breast caner-related quality of life (< 112,8 points on the FACT-B)
排除标准
- •Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
- •Pregnancy
- •Simultaneous participation in other clinical trials
结局指标
主要结局
Breast cancer-related quality of life - total score
时间窗: week 12
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life as a total score of 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
次要结局
- Total number, type, and grade of adverse events(week 26)
- Endocrine symptoms(week 26)
- Number of patients with adverse events(week 26)
- Fear of recurrence(week 26)
- Fatigue(week 26)
- Sleep disturbance(week 26)
- State anxiety(week 26)
- Severity of depressive symptoms(week 26)
- Severity of insomnia(week 26)
- Breast cancer-related quality of life - sub scores(week 26)
- Breast cancer-related quality of life - total score(week 26)
- Breast cancer-related quality of life - sub scores(week 12)
- Fatigue(week 12)
- Endocrine symptoms(week 12)
- Sleep disturbance(week 12)
- Severity of insomnia(week 12)
- State anxiety(week 12)
- Fear of recurrence(week 12)
- Severity of depressive symptoms(week 12)
- Number of patients with adverse events(week 12)
- Total number, type, and grade of adverse events(week 12)
研究者
Heidemarie Haller
Principal Investigator
Universität Duisburg-Essen