Breast Neoplasms, Fatigue
Conditions
Brief summary
Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care. It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.
Interventions
BEHAVIORALIyengar Yoga
* 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes
BEHAVIORALWalking
* 12 weeks of walking * 2 weekly sessions of 60 minutes
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non-metastatic invasive breast cancer * currently receiving adjuvant chemotherapy * moderate to severe chemotherapy-induced fatigue * physical and cognitive capacity to participate in yoga or walking
Exclusion criteria
* diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis * ECOG status \> 1 * prior malignancy with a disease-free survival \< 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix * prior ductal carcinoma in situ (DCIS) ot the breast * pregnancy or breastfeeding * regular practice of yoga or walking during the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Week 12 | Multidimensional Fatigue Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | Week 12, week 36 | Functional Assessment of Cancer Therapy - Breast |
| Depression and anxiety | Week 12, week 36 | Hospital Anxiety and Depression Scale |
| Sleep quality | Week 12, week 36 | Pittsburgh Sleep Quality Index |
| Fatigue | Week 36 | Multidimensional Fatigue Inventory |
| Salivary Cortisol | Week 12, week 36 | Cortisol awakening response |
| Safety | Week 0-36 | Adverse events |
| Perceived Stress | Week 12, week 36 | * Perceived Stress Scale * Impact of Event Scale |
Countries
Germany
Outcome results
None listed