Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners (CRANIO4US)

Universität Duisburg-Essen

Status: Active, not recruiting

Conditions: Breast Cancer; Complementary Therapies

Treatments: Procedure: Treatment as usal / wait list; Procedure: Craniosacral self-help group training; Procedure: Craniosacral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04319510

2019402

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 3 patient groups

Craniosacral therapy

Experimental group

Description:

24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.

Treatment:

Procedure: Craniosacral therapy

Craniosacral self-help group training

Experimental group

Description:

24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.

Treatment:

Procedure: Craniosacral self-help group training

Treatment as usual / wait list control

Other group

Description:

Waiting period of six months.

Treatment:

Procedure: Treatment as usal / wait list