Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
研究概览
简要总结
RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.
Secondary
- Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
- •Patients must have signed an informed consent
排除标准
- •Previous cancer other than skin cancer
- •Previous chemotherapy experience
- •Active substance abuse
- •Schizophrenia
- •Pregnant or lactating
研究组 & 干预措施
Chemotherapy Alone
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or primary peritoneal cancer by their treating physician. Chemotherapy administration is not administered as part of this protocol.
干预措施: Standard chemotherapy (Drug)
Standard Chemotherapy + CAM
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.
干预措施: healing touch (Other)
Standard Chemotherapy + CAM
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.
干预措施: massage therapy (Other)
Standard Chemotherapy + CAM
Patients receiving 6 cycles of taxane and platinum therapy for ovarian, fallopian tube or peritoneal cancer with additional complementary alternative medicine - CAM (healing touch, hypnosis and massage therapy). Chemotherapy administration is not administered as part of this protocol.
干预措施: hypnosis (Other)
结局指标
主要结局
Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)
时间窗: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
Measured by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.
Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM
时间窗: Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy
The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).
次要结局
- Number of Patients With Delays In Receiving Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Number of Patients With Delays In Receiving Chemotherapy Alone(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Anti-Emetic Dose Use After Chemotherapy Alone(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Anti-Emetic Dose Use After Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Natural Killer Cell Count Levels Before Chemotherapy Alone(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Average Natural Killer Cell Count Levels Before Chemotherapy and CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM(Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months))
- Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))
- Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM(Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days))