跳至主要内容
临床试验/NCT00691119
NCT00691119终止不适用

A Feasibility Study of Relaxation and Visualization Therapy for Breast Cancer Patients

National University of Natural Medicine2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy

研究概览

简要总结

The purpose of this study is to find out if it is possible to study relaxation and visualization therapy (RVT) with individuals that have breast cancer. We will also look at what effects, the good and bad, RVT has when used with radiation therapy. We are interested in how RVT may relate to energy, quality of life, stress, and the immune system. Relaxation and Visualization therapy will lead participants through a practice of physical relaxation and then a step by step visualization. In this study, participants will be led through an RVT exercise, providing an interactive process. In addition, women will perform solitary RVT exercises at home on weekends. Participants for this study will be drawn from two OHSU physicians' regular patient base. To be sure that we are testing the effects of RVT alone, we will use three groups. The three groups will be RVT, education, and a control. The RVT group will receive RVT with radiation, and the education group will receive breast cancer related health education with radiation. The third group will receive no treatment beyond radiation. This third group is called the control. The entire study will last for approximately twelve weeks. For the first 6 weeks, each participant will be receiving radiation therapy. We will be particularly interested in the effects that RVT may have on energy, quality of life, stress, and the immune system. No experimental drug or device will be used during the study.

详细描述

The purpose of this study is to find out if it is possible to study relaxation and visualization therapy (RVT) with individuals that have breast cancer. We will also look at what effects, the good and bad, RVT has when used with radiation therapy. We are interested in how RVT may relate to energy, quality of life, stress, and the immune system. Relaxation is a state in which the body slows down, like in sleep or rest. Heart rate decreases, breathing slows and digestion increases. Visualization is an interactive mental process. The participant imagines herself doing a physical activity. This imagination stimulates a measurable physical response. Relaxation and Visualization therapy will lead participants through a practice of physical relaxation and then a step by step visualization. RVT can be performed by an individual alone, or it can be led by a health practitioner. In this study, participants will be led through an RVT exercise, providing an interactive process. In addition, women will perform solitary RVT exercises at home on weekends. Participants for this study will be drawn from two OHSU physicians' regular patient base. Newly diagnosed patients will be offered the opportunity to participate in our Relaxation and Visualization Therapy Study. We want to make sure that the results we see are not due to any other factors. To be sure that we are testing the effects of RVT alone, we will use three groups. The three groups will be RVT, education, and a control. The RVT group will receive RVT with radiation, and the education group will receive breast cancer related health education with radiation. Both test groups will last approximately one hour. The third group will receive no treatment beyond radiation. This third group is called the control. The entire study will last for approximately twelve weeks. For the first 6 weeks, each participant will be receiving radiation therapy. The second 6 weeks will be done mostly at home. We will be particularly interested in the effects that RVT may have on energy, quality of life, stress, and the immune system. To examine this, participants will complete surveys about stress and psychological changes. A dietary assessment will be conducted via interviews. Participants will be asked to recall what foods commonly eaten. A heart monitor will be worn during the educational and visualization activities to monitor any changes in heart rate. Additionally, 5 blood draws will occur during the study, and the total amount of blood drawn will be about 4 tablespoons of blood. No experimental drug or device will be used during the study.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women who have been diagnosed with breast cancer and have been referred to radiotherapy at OHSU
  • between 45 and 70 years of age

排除标准

  • receiving chemotherapy concurrently
  • uses tobacco products
  • has a fear or aversion to blood draws
  • has a history of hypertension
  • uses recreational drugs
  • drinks more than 3-5 alcoholic beverages per week
  • takes any anti-inflammatory medications
  • has a current infection or has a compromised immune system

结局指标

主要结局

Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy

时间窗: Ongoing

Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS)

时间窗: Five days a week for six weeks

次要结局

  • Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale(Once a week for six weeks)
  • Quality of Life [SF-36](Once during week 1, week 6 and week 12 of intervention)
  • Perceived Stress Scale(Once during week 1, week 6 and week 12 of intervention)
  • State and Trait Anxiety Inventory[STAI](Once during week 1, week 6 and week 12 of intervention)
  • Functional Assessment of Cancer Therapy-Breast [FACT-B](Once during week 1, week 6, and week 12 of intervention)
  • Transformative Change Scale(Once during week 1, week 6, and week 12 of intervention)
  • Diet inquiry(once during week 6 and week 12 of intervention)
  • Heart rate monitoring(Five days a week during six week intervention, once during final week 12 visit)
  • Adverse events(During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit)
  • Immune assessments via blood testing: IL-6, IL-1, IL-ra, IL-4, IL-8, IL-10, TNFalpha, IFNgamma, and CRP(Once every other week for 12 week study period)
  • Neurological assessments via blood testing: serotonin, GABA and norepinephrine(Once every other week for the 12 week study period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Zwickey

Dean of Research

National University of Natural Medicine

研究点 (2)

Loading locations...

相似试验