Breast Cancer, Complementary Therapies
Conditions
Keywords
Craniosacral Therapy, Breast cancer, Randomized Controlled Trial, Self-help strategies, Self-efficacy, Coping
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 self-selection to either individual CST or CST self-help group training. For all groups, treatment as usual is allowed.
Interventions
PROCEDURECraniosacral 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.
PROCEDURECraniosacral 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.
PROCEDURETreatment 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 self-selection to 1:1 CST or participation in the CST self-help group training.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| Breast cancer-related quality of life - sub scores | 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. |
| 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 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. |
| Fatigue | 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. |
| Endocrine symptoms | 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. |
| Sleep disturbance | 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. |
| Severity of insomnia | 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. |
| State anxiety | 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. |
| Fear of recurrence | 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. |
| Severity of depressive symptoms | 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. |
| Number of patients with adverse events | 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) |
| Total number, type, and grade of adverse events | 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) |
Countries
Germany
Contacts
STUDY_DIRECTORGustav Dobos, Prof. MD
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Outcome results
None listed