Quality of Life Interventions During Cervical Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in natural killer cell cytotoxicity (NKCC)
研究概览
简要总结
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
详细描述
Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.
排除标准
- •Greater than Stage IVa cervical cancer
- •Metastatic or recurrent cervical cancer
- •Patients receiving only chemotherapy or only radiation therapy
- •History of cancer of any site
- •History of a transplant
- •Diagnosed with any immunosupressive disorder (HIV, AIDS).
结局指标
主要结局
Change in natural killer cell cytotoxicity (NKCC)
时间窗: 6 weeks
Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay.
Number of days of treatment delay due to chemoradiation-related toxicities
时间窗: 6 weeks
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
Change in participant reports of depression
时间窗: 6 weeks
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
Number of chemoradiation-related toxicities
时间窗: 6 weeks
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
次要结局
- Change in participant reports of anxiety(6 weeks)
- Change in metabolomic measures(6 weeks)
- Change in white blood cell counts(6 weeks)
- Change in red blood cell counts(6 weeks)
- Change in participant reports of fatigue(6 weeks)
- Change in participant reports of quality of life(6 weeks)
研究者
Susan Lutgendorf
Professor
University of Iowa