Relaxation and Visualization Therapy for Breast Cancer Patients

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Heather Zwickey, National College of Natural Medicine
ClinicalTrials.gov Identifier:
NCT00691119
First received: June 3, 2008
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Relaxation and Visualization Therapy
Other: Health education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Relaxation and Visualization Therapy for Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by National College of Natural Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 9
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Relaxation and Visualization Therapy group
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 Name: RVT
Active Comparator: B
Health education group
Other: Health education
Facilitated health education sessions, twenty minutes, five times a week for six weeks.
No Intervention: C
Control group

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691119

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
National College of Natural Medicine
Oregon Health and Science University
Investigators
Principal Investigator: Carol Marquez, MD Oregon Health and Science University
Principal Investigator: Heather Zwickey, PhD Helfgott Research Institute at National College of Natural Medicine
  More Information

No publications provided

Responsible Party: Heather Zwickey, Dean of Research, National College of Natural Medicine
ClinicalTrials.gov Identifier: NCT00691119     History of Changes
Other Study ID Numbers: IRB00003439
Study First Received: June 3, 2008
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National College of Natural Medicine:
breast cancer
radiation
Relaxation and Visualization Therapy
relaxation
visualization
RVT
complementary and alternative medicine
CAM
alternative medicine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014