Relaxation and Visualization Therapy for Breast Cancer Patients

NCT ID: NCT00691119

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

A

Relaxation and Visualization Therapy group

Group Type: EXPERIMENTAL

Relaxation and Visualization Therapy

Intervention Type: BEHAVIORAL

Twenty minutes of facilitated relaxation and visualization therapy five days a week for six weeks. Self practice of 20 minutes per day for the next six weeks.

B

Health education group

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: OTHER

Facilitated health education sessions, twenty minutes, five times a week for six weeks.

C

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relaxation and Visualization Therapy

Twenty minutes of facilitated relaxation and visualization therapy five days a week for six weeks. Self practice of 20 minutes per day for the next six weeks.

Intervention Type: BEHAVIORAL

Health education

Facilitated health education sessions, twenty minutes, five times a week for six weeks.

Intervention Type: OTHER

Other Intervention Names

RVT

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

National University of Natural Medicine

OTHER

Sponsor Role: lead

Responsible Party

Heather Zwickey

Dean of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carol Marquez, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Heather Zwickey, PhD

Role: PRINCIPAL_INVESTIGATOR

Helfgott Research Institute at National College of Natural Medicine

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00003439

Identifier Type: -

Identifier Source: org_study_id