跳至主要内容
临床试验/NCT04319510
NCT04319510
已完成
不适用

Supportive Effects of Craniosacral Therapy for Women With Breast Cancer: a Randomized Controlled Trial

Universität Duisburg-Essen3 个研究点 分布在 1 个国家目标入组 102 人2023年9月18日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Breast Cancer
发起方
Universität Duisburg-Essen
入组人数
102
试验地点
3
主要终点
Breast cancer-related quality of life - total score
状态
已完成
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2023年9月18日
结束日期
2025年9月11日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Heidemarie Haller

Principal Investigator

Universität Duisburg-Essen

入排标准

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 37 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)

研究点 (3)

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