Relaxation and Visualization Therapy for Breast Cancer Patients

• Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  
• Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS) [ Time Frame: Five days a week for six weeks ] [ Designated as safety issue: Yes ]
  

• Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale [ Time Frame: Once a week for six weeks ] [ Designated as safety issue: Yes ]
  
• Quality of Life [SF-36] [ Time Frame: Once during week 1, week 6 and week 12 of intervention ] [ Designated as safety issue: No ]
  
• Perceived Stress Scale [ Time Frame: Once during week 1, week 6 and week 12 of intervention ] [ Designated as safety issue: No ]
  
• State and Trait Anxiety Inventory[STAI] [ Time Frame: Once during week 1, week 6 and week 12 of intervention ] [ Designated as safety issue: No ]
  
• Functional Assessment of Cancer Therapy-Breast [FACT-B] [ Time Frame: Once during week 1, week 6, and week 12 of intervention ] [ Designated as safety issue: No ]
  
• Transformative Change Scale [ Time Frame: Once during week 1, week 6, and week 12 of intervention ] [ Designated as safety issue: No ]
  
• Diet inquiry [ Time Frame: once during week 6 and week 12 of intervention ] [ Designated as safety issue: No ]
  
• Heart rate monitoring [ Time Frame: Five days a week during six week intervention, once during final week 12 visit ] [ Designated as safety issue: No ]
  
• Adverse events [ Time Frame: During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit ] [ Designated as safety issue: Yes ]
  
• Immune assessments via blood testing: IL-6, IL-1, IL-ra, IL-4, IL-8, IL-10, TNFalpha, IFNgamma, and CRP [ Time Frame: Once every other week for 12 week study period ] [ Designated as safety issue: No ]
  
• Neurological assessments via blood testing: serotonin, GABA and norepinephrine [ Time Frame: Once every other week for the 12 week study period ] [ Designated as safety issue: No ]
  

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.