Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

Study Overview
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Brief Summary
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Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.

Official Title
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Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer

Conditions
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Menopause, Breast Cancer

Intervention / Treatment
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* Behavioral: Yoga
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer (Stage I-III) After completion of surgical therapy After completion of adjuvant radiotherapy and chemotherapy Score of 5 or greater on the Menopausal Rating Scale Physical and cognitive capacity to participate in the yoga intervention Willingness to participate in 10 or more of the 12 yoga interventions signed informed consent Exclusion Criteria: Regular yoga practice in the past 12 months Planned surgery in the study period Diagnosed and medically treated psychosis Hormone replacement therapy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation | Behavioral: Yoga<br> <br> Other: Usual care<br> <br> |
| Other: Usual care<br>Patients continue usual care by their practitioner | Other: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptoms | Menopause Rating Scale | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (disease-specific) | Functional Assessment of Cancer Therapy - Breast | Week 12 | 
| Fatigue | Functional Assessment of Chronic Illness Therapy - Fatigue | Week 12 | 
| Anxiety | Hospital Anxiety and Depression Scale | Week 12 | 
| Depression | Hospital Anxiety and Depression Scale | Week 12 | 
| Menopausal symptoms | Menopause Rating Scale | Week 24 | 
| Health-related quality of life (disease-specific) | Functional Assessment of Cancer Therapy - Breast | Week 24 | 
| Fatigue | Functional Assessment of Chronic Illness Therapy - Fatigue | Week 24 | 
| Anxiety | Hospital Anxiety and Depression Scale | Week 24 | 
| Depression | Hospital Anxiety and Depression Scale | Week 24 | 
| Adverse events |  | Week 12 | 
| Adverse events |  | Week 24 |