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

45 Years
70 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

Inclusion Criteria:

- women who have been diagnosed with breast cancer and have been referred to
radiotherapy at OHSU

- between 45 and 70 years of age

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Carol Marquez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • radiation
  • Relaxation and Visualization Therapy
  • relaxation
  • visualization
  • RVT
  • complementary and alternative medicine
  • CAM
  • alternative medicine
  • Breast Neoplasms



Oregon Health and Science UniversityPortland, Oregon  97201