Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina. Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness. This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
详细描述
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
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
- Single (Care Provider)
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
- •Diagnosis of any invasive gynecologic cancer without evidence of disease.
- •Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- •Able to speak, read and write English
- •ECOG Performance Status between 0 and 3
- •Subjects must have a phone.
- •Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- •Expected to continue cancer care at UWCCC for the duration of the study.
排除标准
- •Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- •Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- •Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- •Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- •Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
- •Prisoner or incarcerated
结局指标
主要结局
Change in anxiety
时间窗: Baseline to up to 5 months
Measured by the 8-item anxiety subscale of the PROMIS scale.
次要结局
- Change in sleep disturbance(Baseline to up to 5 months)
- Change in fatigue(Baseline to up to 5 months)
- Change in sexual function(Baseline to up to 5 months)
- Change in cortisol levels(Baseline to up to 5 months)
- Change in levels of pro-inflammatory cytokines(Baseline to up to 5 months)
- Change in NK cell function(Baseline to up to 5 months)
- Change in depression(Baseline to up to 5 months)
- Change in existential/spiritual distress(Baseline to up to 5 months)
- Change in cognitive function(Baseline to up to 5 months)
- Change in immune cell phenotypes(Baseline to up to 5 months)