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NCT Number: NCT04319510

Supportive Effects of Craniosacral Therapy for Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Complementary Therapies Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Breast Unit, Evang. Kliniken Essen-Mitte, Essen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. Breast cancer-related quality of life - total score

    Time frame: week 12

    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.

Secondary outcomes

  1. Breast cancer-related quality of life - sub scores

    Time frame: week 12

    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 on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.

  2. Breast cancer-related quality of life - total score

    Time frame: week 26

    Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire: The FACT-B consists of 37 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.

  3. Breast cancer-related quality of life - sub scores

    Time frame: week 26

    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 on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.

  4. Fatigue

    Time frame: week 12

    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.

  5. Fatigue

    Time frame: 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.

  6. Endocrine symptoms

    Time frame: week 12

    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.

  7. Endocrine symptoms

    Time frame: 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.

  8. Sleep disturbance

    Time frame: week 12

    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.

  9. Sleep disturbance

    Time frame: 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.

  10. Severity of insomnia

    Time frame: week 12

    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.

  11. Severity of insomnia

    Time frame: 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.

  12. State anxiety

    Time frame: week 12

    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.

  13. State anxiety

    Time frame: 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.

  14. Fear of recurrence

    Time frame: week 12

    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.

  15. Fear of recurrence

    Time frame: 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.

  16. Severity of depressive symptoms

    Time frame: week 12

    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.

  17. Severity of depressive symptoms

    Time frame: 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.

  18. Number of patients with adverse events

    Time frame: week 12

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

  19. Number of patients with adverse events

    Time frame: 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)

  20. Total number, type, and grade of adverse events

    Time frame: week 12

    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)

  21. Total number, type, and grade of adverse events

    Time frame: 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)

Other outcomes

  1. Expectations about treatment efficacy

    Time frame: week 0

    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.

  2. Expectations about self-efficacy

    Time frame: week 0

    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.

  3. Treatment Credibility

    Time frame: week 12

    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.

  4. Relation between therapist and patient

    Time frame: week 12

    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.

  5. Actually received social support

    Time frame: week 12

    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.

  6. Actually received social support

    Time frame: week 26

    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.

  7. Body Awareness

    Time frame: week 12

    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.

  8. Body Awareness

    Time frame: week 26

    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.

  9. Interview

    Time frame: week 12

    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.

  10. Craniosacral-specific quality of life

    Time frame: week 12

    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.

  11. Craniosacral-specific quality of life

    Time frame: week 26

    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.

  12. Duration of homework

    Time frame: week 1-12

    The duration of performing the CST techniques at home (for group 2) will be assessed using a diary.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Supportive Effects of Craniosacral Therapy for Women With Breast Cancer: a Randomized Controlled Trial

Acronym: CRANIO4US

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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