This trial studies how well yoga therapy works during chemotherapy and radiation treatment in improving physical and emotional well-being in patients with stage IB2-IIIB cervical cancer. Yoga therapy may help to balance the mind and body through exercise, meditation (focusing thoughts), and control of breathing and emotions.
PRIMARY OBJECTIVE: I. Establish feasibility of delivering a yoga therapy program during chemotherapy and radiation therapy (CRT) for loco-regionally advanced cervical cancer undergoing chemo-radiotherapy. SECONDARY OBJECTIVES: I. Measure the effects and variance of yoga on fatigue, depression, anxiety, pelvic pain and over-all quality of life (QOL) in cervical cancer (CxCa) patients undergoing primary treatment with CRT. II. Examine changes in other psychosocial outcomes including ability to find meaning in the illness, spirituality and sexuality. EXPLORATORY OBJECTIVE: I. Evaluate whether markers of stress response (plasma levels of other pro-inflammatory cytokines, including interleukin-6 \[IL-6\], and IL-8, IL-10, VEGF, and CRP) change in response to yoga therapy and their association with fatigue, depression, anxiety, pelvic pain, meaning in the illness, experience, spirituality, and QOL in CxCa patients undergoing primary CRT. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (YOGA GROUP): Patients attend at least 2 yoga classes per week over 5-6 weeks lasting approximately 60 minutes each for up to 15 classes during the CRT. Patients also complete surveys pre-treatment, once a week, and post-treatment and receive a yoga manual and DVD during and after CRT. GROUP II (WAIT LIST CONTROL): Patients refrain from participating in any new stress management activities and receive a DVD. Patients are also offered 4 group yoga classes after 3 months of CRT. Patients also complete surveys as in Group I.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Receive DVD
Ancillary studies
Ancillary studies
Ancillary studies
Attend yoga class
M D Anderson Cancer Center
Houston, Texas, United States
Enrollment to the yoga therapy protocol
90 patients will be screen to obtain at least 40 who are eligible and consent
Time frame: Baseline up to 3 months post CRT
Adherence to the yoga therapy protocol
At least 10 patients in the YG group must complete at least 50% of the required yoga sessions
Time frame: Baseline up to 3 months post CRT
Completion in the yoga therapy protocol
At least 25 of the 40 patients must complete any of the follow up measure between T3 and T5 in order to declare this study feasible
Time frame: Baseline up to 3 months post CRT
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