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

Study Overview
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Brief Summary
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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.

Official Title
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Supportive Effects of Craniosacral Therapy for Female Patients With Breast Cancer and Their Partners: a Randomized Controlled Trial

Conditions
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Breast Cancer, Complementary Therapies

Intervention / Treatment
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* Procedure: Craniosacral therapy
* Procedure: Craniosacral self-help group training
* Procedure: Treatment as usal / wait list


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral therapy<br>24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. | Procedure: Craniosacral therapy<br>* 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.<br>|
| Experimental: Craniosacral self-help group training<br>24 CST units à 45 minutes over 12 weeks. Follow-up assessment 6 months after randomization. | Procedure: Craniosacral self-help group training<br>* 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.<br>|
| Other: Treatment as usual / wait list control<br>Waiting period of six months. | Procedure: Treatment as usal / wait list<br>* 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 2 treatments (4TUS) of 1:1 CST and the participation in the group training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-related quality of life - total score | 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. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-related quality of life - sub scores | 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. | week 12 | 
| Breast cancer-related quality of life - total score | 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. | week 26 | 
| Breast cancer-related quality of life - sub scores | 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. | week 26 | 
| Fatigue | 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. | week 12 | 
| Fatigue | 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. | week 26 | 
| Endocrine symptoms | 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. | week 12 | 
| Endocrine symptoms | 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. | week 26 | 
| Sleep disturbance | 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. | week 12 | 
| Sleep disturbance | 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. | week 26 | 
| Severity of insomnia | 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. | week 12 | 
| Severity of insomnia | 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. | week 26 | 
| State anxiety | 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. | week 12 | 
| State anxiety | 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. | week 26 | 
| Fear of recurrence | 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. | week 12 | 
| Fear of recurrence | 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. | week 26 | 
| Severity of depressive symptoms | 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. | week 12 | 
| Severity of depressive symptoms | 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. | week 26 | 
| Number of patients with adverse events | The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) | week 12 | 
| Number of patients with adverse events | The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) | week 26 | 
| Total number, type, and grade of adverse events | 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) | week 12 | 
| Total number, type, and grade of adverse events | 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) | week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniosacral Therapy, Breast cancer, Randomized Controlled Trial, Self-help strategies, Self-efficacy, Coping