Breast Neoplasm
Conditions
Keywords
Fatigue, Yoga, Anxiety, Quality of Life
Brief summary
A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.
Interventions
BEHAVIORALYoga
Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III. * Treatment completion within the past calendar year. * Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group. * Life expectancy of greater than 1 year. * Karnofsky ≥ 60%; see Appendix A. * Women of childbearing potential are eligible for this study. * Pregnant women are eligible for this study pending a doctor's note. * The ability to understand and complete the study questionnaires. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients with known metastasis. * Patients who are actively participating in a yoga class. * Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Analyze symptoms of depression and anxiety | 8 weeks |
Countries
United States
Outcome results
None listed