Clinical trial NCT00691119: Relaxation and Visualization Therapy for Breast Cancer Patients
Official title: A Feasibility Study of Relaxation and Visualization Therapy for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
radiation
Relaxation and Visualization Therapy
relaxation
visualization
RVT
complementary and alternative medicine
CAM
alternative medicine
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2008-06-05
Enrollment: 9
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy
timeFrame: Ongoing
measure: Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS)
timeFrame: Five days a week for six weeks
Secondary outcomes:
measure: Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale
timeFrame: Once a week for six weeks
measure: Quality of Life [SF-36]
timeFrame: Once during week 1, week 6 and week 12 of intervention
measure: Perceived Stress Scale
timeFrame: Once during week 1, week 6 and week 12 of intervention
measure: State and Trait Anxiety Inventory[STAI]
timeFrame: Once during week 1, week 6 and week 12 of intervention
measure: Functional Assessment of Cancer Therapy-Breast [FACT-B]
timeFrame: Once during week 1, week 6, and week 12 of intervention
measure: Transformative Change Scale
timeFrame: Once during week 1, week 6, and week 12 of intervention
measure: Diet inquiry
timeFrame: once during week 6 and week 12 of intervention
measure: Heart rate monitoring
timeFrame: Five days a week during six week intervention, once during final week 12 visit
measure: Adverse events
timeFrame: During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit
measure: Immune assessments via blood testing: IL-6, IL-1, IL-ra, IL-4, IL-8, IL-10, TNFalpha, IFNgamma, and CRP
timeFrame: Once every other week for 12 week study period
measure: Neurological assessments via blood testing: serotonin, GABA and norepinephrine
timeFrame: Once every other week for the 12 week study period
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Carol Marquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helfgott Research Institute at National College of Natural Medicine
name: Heather Zwickey, PhD
role: PRINCIPAL_INVESTIGATOR
References: