Clinical trial NCT04319510: Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners
Official title: Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Complementary Therapies
Keywords: Craniosacral Therapy
Breast cancer
Randomized Controlled Trial
Self-help strategies
Self-efficacy
Coping
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 to take part in two individual CST interventions and the CST self-help training. For all groups, treatment as usual is allowed.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period
* Pregnancy
* Simultaneous participation in other clinical trials

Primary outcomes:
measure: Breast cancer-related quality of life - total score
timeFrame: week 12
Secondary outcomes:
measure: Breast cancer-related quality of life - sub scores
timeFrame: week 12
measure: Breast cancer-related quality of life - total score
timeFrame: week 26
measure: Breast cancer-related quality of life - sub scores
timeFrame: week 26
measure: Fatigue
timeFrame: week 12
measure: Fatigue
timeFrame: week 26
measure: Endocrine symptoms
timeFrame: week 12
measure: Endocrine symptoms
timeFrame: week 26
measure: Sleep disturbance
timeFrame: week 12
measure: Sleep disturbance
timeFrame: week 26
measure: Severity of insomnia
timeFrame: week 12
measure: Severity of insomnia
timeFrame: week 26
measure: State anxiety
timeFrame: week 12
measure: State anxiety
timeFrame: week 26
measure: Fear of recurrence
timeFrame: week 12
measure: Fear of recurrence
timeFrame: week 26
measure: Severity of depressive symptoms
timeFrame: week 12
measure: Severity of depressive symptoms
timeFrame: week 26
measure: Number of patients with adverse events
timeFrame: week 12
measure: Number of patients with adverse events
timeFrame: week 26
measure: Total number, type, and grade of adverse events
timeFrame: week 12
measure: Total number, type, and grade of adverse events
timeFrame: week 26
Other outcomes:
measure: Expectations about treatment efficacy
timeFrame: week 0
measure: Expectations about self-efficacy
timeFrame: week 0
measure: Treatment Credibility
timeFrame: week 12
measure: Relation between therapist and patient
timeFrame: week 12
measure: Actually received social support
timeFrame: week 12
measure: Actually received social support
timeFrame: week 26
measure: Body Awareness
timeFrame: week 12
measure: Body Awareness
timeFrame: week 26
measure: Interview
timeFrame: week 12
measure: Craniosacral-specific quality of life
timeFrame: week 12
measure: Craniosacral-specific quality of life
timeFrame: week 26
measure: Duration of homework
timeFrame: week 1-12
Locations:
city: Essen
country: Germany
facility: Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
city: Essen
country: Germany
facility: Breast Unit, Evang. Kliniken Essen-Mitte
city: Essen
country: Germany
facility: Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen
Study officials:
affiliation: Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References: