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

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

The number of patients with adverse events and serious adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE)

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)

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)

Treatment Credibility Scale (TCS): The TCS consists of 4 self-report items, which are answered on a Numeric Rating Scale (NRS). One item asks about the expectations of efficacy of the study treatments and 3 items about treatment credibility (see below). A higher score indicates higher treatment expectations.

Numeric Rating Scale (NRS): Expectations about the self-efficacy of performing the learned CST techniques at home were assessed using a self-report NRS. A higher score indicates higher expectations of self-efficacy.

Treatment Credibility Scale (TCS): The TCS consists of 4 self-report items, which are answered on a Numeric Rating Scale (NRS). One item asks about the expectations of efficacy of the study treatments (se above) and 3 items about treatment credibility. A higher score indicates higher treatment credibility.

Helping Alliance Questionnaire (HAQ): The HAQ consists of 11self-report items and assesses the therapeutic relation on two subscales: quality of the therapeutic relation and satisfaction with the treatment. A higher score indicates a higher quality of the therapeutic relation / a higher satisfaction with the treatment.

Berlin Social Support Scales - Actually Received Support (BSSS-ARS) subscale: The BSSS-ARS consists of 15 self-report items and assesses the actually received social support on 4 subscales: emotional support, instrumental support, informational support, and satisfaction with support. A higher score indicates higher received social support.

Berlin Social Support Scales - Actually Received Support (BSSS-ARS) subscale: The BSSS-ARS consists of 15 self-report items and assesses the actually received social support on 4 subscales: emotional support, instrumental support, informational support, and satisfaction with support. A higher score indicates higher received social support.

Body Responsiveness Questionnaire (BRQ): The BRQ consists of 7 self-report items and assesses body awareness on 3 subscales: Importance of Interoceptive Awareness, Perceived Connection, and Suppression of Bodily Sensations. A higher score indicates higher body awareness on the subscales Importance of Interoceptive Awareness and Perceived Connection, while a higher score indicates lower body awareness on the subscale Suppression of Bodily Sensations.

Body Responsiveness Questionnaire (BRQ): The BRQ consists of 7 self-report items and assesses body awareness on 3 subscales: Importance of Interoceptive Awareness, Perceived Connection, and Suppression of Bodily Sensations. A higher score indicates higher body awareness on the subscales Importance of Interoceptive Awareness and Perceived Connection, while a higher score indicates lower body awareness on the subscale Suppression of Bodily Sensations.

Semi-structured interview: A pre-developed semi-structured interview guide asks about the personal experiences with the effects and safety of craniosacral therapy/self-help techniques.

Warwick Holistic Health Questionnaire (WHHQ): The WHHQ consists of 25 self-report items and assesses craniosacral-specific quality of life on one scale. A higher score indicates higher craniosacral-specific quality of life. The German version of the WHHQ shall be validated within this trial.

Warwick Holistic Health Questionnaire (WHHQ): The WHHQ consists of 25 self-report items and assesses craniosacral-specific quality of life on one scale. A higher score indicates higher craniosacral-specific quality of life. The German version of the WHHQ shall be validated within this trial.

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

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

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