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This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.
Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind body medicine day care clinic | Experimental | Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education |
|
| Usual care | Other | Patients continue usual care by their practitioner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind body medicine day care clinic | Behavioral | Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education |
| Measure | Description | Time Frame |
|---|---|---|
| Menopausal symptoms | Menopause Rating Scale (MRS) | week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| General health-related quality of life | Functional Assessment of Cancer Therapy - General Questionaire (FACT-G) | week 11 |
| Spiritual health-related quality of life | Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP) |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness | Conscious Presence and Self Control Scale (CPSC) | week 11 |
| Social Support | Berlin Social Support Scale (BSSS) | week 11 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof. MD | Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evang. Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45276 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Usual care | Other | Patients continue usual care by their practitioner |
|
| week 11 |
| Fatigue | Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F) | week 11 |
| Mental wellbeing | Hospital Anxiety and Depression Scale (HADS) | week 11 |
| Stress | Perceived Stress Scale (PSS) | week 11 |
| Compliance | Medication Adherence Report Scale (MARS) | week 11 |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | week 11 |
| Menopausal smptoms | Menopause Rating Scale (MRS) | week 23 |
| Genaeral health-related quality of life | Functional Assessment of Cancer Therapy - General Questionaire (FACT-G) | week 23 |
| Spiritual health-related quality of life | Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP) | week 23 |
| Fatigue | Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F) | week 23 |
| Mental wellbeing | Hospital Anxiety and Depression Scale (HADS) | week 23 |
| Stress | Perceived Stress Scale (PSS) | week 23 |
| Compliance | Medication Adherence Report Scale (MARS) | week 23 |
| Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | week 23 |
| Expectation | Visual Analogue Scale (VAS) | week 0 |
| Statisfaction | Client Satisfaction Questionnaire (CSQ) | week 11 |
| D017437 |
| Skin and Connective Tissue Diseases |