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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Complementary Therapies
• Interventions: Procedure: Craniosacral therapy; Procedure: Craniosacral self-help group training; Procedure: Treatment as usal / wait list

• Registration Number: NCT04319510
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-24
• Study Start: 2023-09-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Craniosacral therapy	Craniosacral therapy	24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.
Craniosacral self-help group training	Craniosacral self-help group training	24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization.
Treatment as usual / wait list control	Treatment as usal / wait list	Waiting period of six months.

Primary Outcome Measures

Name	Time	Method
Breast cancer-related quality of life - total score	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.

Secondary Outcome Measures

Name	Time	Method
Total number, type, and grade of adverse events	week 26	The total number, type and grade of adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Breast cancer-related quality of life - total score	week 26	Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 44 self-report items (4 general subscales and one breast-cancer specific subscale, which will be summarized to a total score) and assesses the specific breast cancer-related quality of life. A higher score indicates a higher cancer-related quality of life.
Endocrine symptoms	week 26	Funcitonal Assessment of Cancer - Endocrine Symptom (FACT-ES) Questionnaire: The additonal ES-scale of the FACT consists of 19 self-report items and assesses symptoms related to the endocrine system / antihormonal therapy on 1 scale. A higher score indicates a higher endocrine symptoms.
Number of patients with adverse events	week 26	The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Breast cancer-related quality of life - sub scores	week 26	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 on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Fear of recurrence	week 26	The Fear of Relapse/Recurrence Scale (FRRS): The FRRS consists of 5 self-report items and assesses the fear of cancer recurrence on one scale. A higher score indicates higher fear of recurrence.
Fatigue	week 26	Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Questionnaire: The addoitional F-scale of the FACT consists of 13 self-report items and assesses fatigue related to cancer on 1 scale. A higher score indicates a higher cancer-related fatigue.
Sleep disturbance	week 26	Patient related outcomes measurement information system - sleep disturbance (PROMIS-SD) Short form: The SD-short form of the PROMIS consists of 8 self-report items and assesses the disturbance of sleep on 1 scale. A higher score indicates higher disturbances of the sleep.
State anxiety	week 26	Patient related outcomes measurement information system - anxiety/emotional distress (PROMIS-A/ED) Short form: The A/ED-short form of the PROMIS consists of 7 self-report items and assesses state anxiety on one scale. A higher score indicates higher anxiety.
Severity of depressive symptoms	week 26	Center for epdiemiologic studies depression scale (CES-D): The CES-D consists of 10 self-report items and assesses the severity of depressive symptoms on one scale. A higher score indicates higher severity of depressive symptoms.
Severity of insomnia	week 26	Insomnia Severity Index (ISI): The ISI consists of 7 self-report items and assesses the severity of insomnia on 1 scale. A higher score indicates higher severity of insomnia.

Trial Locations

Locations (3)

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen; 🇩🇪 Essen, Germany

Breast Unit, Evang. Kliniken Essen-Mitte; 🇩🇪 Essen, Germany

Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen; 🇩🇪 Essen, Germany