Supportive Effects of Craniosacral Therapy for Women With Breast Cancer

NCT04319510 | Completed

• 1 other identifier: 2019402
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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 self-selection to either individual CST or CST self-help group training. For all groups, treatment as usual is allowed.

Conditions

Breast Cancer; Complementary Therapies

Keywords

Craniosacral Therapy; Breast cancer; Randomized Controlled Trial; Self-help strategies; Self-efficacy; Coping

Outcome Measures

Primary Outcomes (1)

• Breast cancer-related quality of life - total score

  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.

  week 12

Secondary Outcomes (21)

• Breast cancer-related quality of life - sub scores

  week 12

• Breast cancer-related quality of life - total score

  week 26

• Breast cancer-related quality of life - sub scores

  week 26

• Fatigue

  week 12

• Fatigue

  week 26

Other Outcomes (12)

• Expectations about treatment efficacy

  week 0

• Expectations about self-efficacy

  week 0

• Treatment Credibility

  week 12

Study Arms (3)

Craniosacral therapy

EXPERIMENTAL

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

Procedure: Craniosacral therapy

Craniosacral self-help group training

EXPERIMENTAL

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

Procedure: Craniosacral self-help group training

Treatment as usual / wait list control

OTHER

Waiting period of six months.

Procedure: Treatment as usal / wait list

Interventions

Craniosacral therapy PROCEDURE

The first experimental group of patients will receive 24 units à 45 minutes over 12 weeks (2 consecutive units per week) offered by a trained craniosacral therapist within a 1:1 setting. Treatment as usual is allowed.

Craniosacral therapy

Craniosacral self-help group training PROCEDURE

The second experimental group of patients will receive 24 teaching units (TUs) à 45 minutes over 12 weeks offered by a trained craniosacral therapist within a group setting. The group training will start with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients have to agree to participate in the introductory day and 90% of the following TUs. All patients will receive a script with theoretical CST information and descriptions of the learned techniques, which should facilitate the correct practice at home. Treatment as usual is allowed.

Craniosacral self-help group training

Treatment as usal / wait list PROCEDURE

The control group will receive no specific study treatment for a waiting period of six months. Treatment as usual is allowed. Afterwards they were offered self-selection to 1:1 CST or participation in the CST self-help group training.

Treatment as usual / wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (3)

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Essen, 45130, Germany

Location

Breast Unit, Evang. Kliniken Essen-Mitte

Essen, 45276, Germany

Location

Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen

Essen, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Therapeutics; Waiting Lists

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Gustav Dobos, Prof. MD

  Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: September 18, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)