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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Cramer, PhD; Email: holger.cramer@med.uni-tuebingen.de
• Study Contact Backup: Name: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de

Study Locations

• Germany
  • Essen, Germany, 45130
    • Recruiting
    • Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
    • Contact: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de
  • Essen, Germany, 45276
    • Recruiting
    • Breast Unit, Evang. Kliniken Essen-Mitte
    • Contact: Sherko Kümmel, Prof. MD; Email: d.schindowski@kem-med.com
    • Contact: Petra Voiss, MD; Email: p.voiss@kem-med.com
  • Essen, Germany
    • Recruiting
    • Department of Gynecology and Obstetrics, University Hospital Essen, University of Duisburg-Essen
    • Contact: Rainer Kimmig, Prof. MD; Email: studienkoordination.frauenklinik@uk-essen.de
    • Contact: Oliver Hoffmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectations about treatment 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 and 3 items about treatment credibility (see below). A higher score indicates higher treatment expectations.	week 0
Expectations about self-efficacy	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.	week 0
Treatment Credibility	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.	week 12
Relation between therapist and patient	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.	week 12
Actually 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.	week 12
Actually 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.	week 26
Body Awareness	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.	week 12
Body Awareness	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.	week 26
Interview	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.	week 12
Craniosacral-specific quality of life	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.	week 12
Craniosacral-specific quality of life	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.	week 26
Duration of homework	The duration of performing the CST techniques at home (for group 2) will be assessed using a diary.	week 1-12

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Study Director: Gustav Dobos, Prof. MD, Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Randomized Controlled Trial; Craniosacral Therapy; Self-help strategies; Self-efficacy; Coping
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2019402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No