Relaxation and Visualization Therapy for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00691119
• Other study ID #: IRB00003439
• Status: Terminated
• Phase: N/A
• First received: June 3, 2008
• Last updated: May 8, 2013
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2013
• Source: National College of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Other:
• Health education
Facilitated health education sessions, twenty minutes, five times a week for six weeks.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
National College of Natural Medicine	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy		Ongoing	No
Primary	Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS)		Five days a week for six weeks	Yes
Secondary	Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale		Once a week for six weeks	Yes
Secondary	Quality of Life [SF-36]		Once during week 1, week 6 and week 12 of intervention	No
Secondary	Perceived Stress Scale		Once during week 1, week 6 and week 12 of intervention	No
Secondary	State and Trait Anxiety Inventory[STAI]		Once during week 1, week 6 and week 12 of intervention	No
Secondary	Functional Assessment of Cancer Therapy-Breast [FACT-B]		Once during week 1, week 6, and week 12 of intervention	No
Secondary	Transformative Change Scale		Once during week 1, week 6, and week 12 of intervention	No
Secondary	Diet inquiry		once during week 6 and week 12 of intervention	No
Secondary	Heart rate monitoring		Five days a week during six week intervention, once during final week 12 visit	No
Secondary	Adverse events		During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit	Yes
Secondary	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	No
Secondary	Neurological assessments via blood testing: serotonin, GABA and norepinephrine		Once every other week for the 12 week study period	No