Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.

Detailed Description
-----------------
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.

Official Title
-----------------
Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Mind body medicine day care clinic
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosed breast cancer (Stage I-III), no metastases Current endocrine therapy (minimum 3 months) Score of 9 or greater on the Menopausal Rating Scale (MRS) Signed informed consent Exclusion Criteria: Severe other somatic or psychiatric comorbidity Pregnancy Planned or existing chemotherapy, radiation or other cure treatment Participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind body medicine day care clinic<br>Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education | Behavioral: Mind body medicine day care clinic<br>* Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education<br>|
| Other: Usual care<br>Patients continue usual care by their practitioner | Other: Usual care<br>* Patients continue usual care by their practitioner<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptoms | Menopause Rating Scale (MRS) | week 11 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, meopausal syptoms, mind body medecine, yoga, acupuncture