Yoga Therapy During Chemotherapy and Radiation Treatment for Local-Regional Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Enrollment to the yoga therapy protocol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Score of =< 2 on Eastern Cooperative Oncology Group (ECOG) performance scale
- •Able to speak English
- •Federation of Gynecology and Obstetrics (FIGO) stage IB2 through IIIB biopsy-proven CxCa (adenocarcinoma, squamous cell carcinoma, and adenosquamous) with plan to undergo curative outpatient CRT at main campus MD Anderson Cancer Center
排除标准
- •Medically documented restrictions at enrollment that could interfere with participation in the yoga interventions (i.e. uncontrolled vaginal bleeding)
- •Medical illness that would prevent administration of full-dose chemotherapy
- •Concurrent diagnosis of a second cancer
- •Prior hysterectomy
- •Neuroendocrine histology
- •Patients who are pregnant
- •It is standard procedure to administer a pregnancy test before the start of CRT. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT) or testing of the blood. Due to radiation and the nature of the disease, a patient becoming pregnant while on study is highly unlikely. In the event a patient were to get pregnant, they would be removed from study because their radiation therapy (RT) might be stopped or fetus would be terminated, which might influence other parameters that are being measured
- •Patients with major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)
- •Patients with extreme mobility issues, and
- •Patients who have had a regular yoga practice (at least one time a month) in past 6 months prior to study enrollment or who are currently engaged in a regular mind-body practice
研究组 & 干预措施
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 over and receive a yoga manual and DVD during and after CRT.
干预措施: Questionnaire Administration (Other)
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 over and receive a yoga manual and DVD during and after CRT.
干预措施: Survey Administration (Other)
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 over and receive a yoga manual and DVD during and after CRT.
干预措施: Yoga (Procedure)
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 over and receive a yoga manual and DVD during and after CRT.
干预措施: Media Intervention (Other)
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 over and receive a yoga manual and DVD during and after CRT.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Media Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Enrollment to the yoga therapy protocol
时间窗: Baseline up to 3 months post CRT
90 patients will be screen to obtain at least 40 who are eligible and consent
Adherence to the yoga therapy protocol
时间窗: Baseline up to 3 months post CRT
At least 10 patients in the YG group must complete at least 50% of the required yoga sessions
Completion in the yoga therapy protocol
时间窗: Baseline up to 3 months post CRT
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
次要结局
未报告次要终点