Breast CancerNCT00691119
Relaxation and Visualization Therapy for Breast Cancer Patients
A study testing Relaxation and Visualization Therapy and Health education in people with Breast Cancer, run by National University of Natural Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Relaxation and Visualization Therapy and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women who have been diagnosed with breast cancer and have been referred to radiotherapy at OHSU
- between 45 and 70 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: 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 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.
Read the 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
- Being tested
- Relaxation and Visualization Therapy, Health education
- Keywords
- breast cancer, radiation, Relaxation and Visualization Therapy, relaxation, visualization, RVT, complementary and alternative medicine, CAM, alternative medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and Visualization TherapyBehavioural
Also called RVT
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.
Health educationOther
Facilitated health education sessions, twenty minutes, five times a week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Relaxation and Visualization Therapy group Receives: Behavioral: Relaxation and Visualization Therapy |
| B | Active comparator | Health education group Receives: Other: Health education |
| C | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy
Measured: Ongoing
Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS)
Measured: Five days a week for six weeks
Secondary outcomes (11)
Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale
Measured: Once a week for six weeks
Quality of Life [SF-36]
Measured: Once during week 1, week 6 and week 12 of intervention
Perceived Stress Scale
Measured: Once during week 1, week 6 and week 12 of intervention
State and Trait Anxiety Inventory[STAI]
Measured: Once during week 1, week 6 and week 12 of intervention
Functional Assessment of Cancer Therapy-Breast [FACT-B]
Measured: Once during week 1, week 6, and week 12 of intervention
Transformative Change Scale
Measured: Once during week 1, week 6, and week 12 of intervention
Diet inquiry
Measured: once during week 6 and week 12 of intervention
Heart rate monitoring
Measured: Five days a week during six week intervention, once during final week 12 visit
Adverse events
Measured: During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit
Immune assessments via blood testing: IL-6, IL-1, IL-ra, IL-4, IL-8, IL-10, TNFalpha, IFNgamma, and CRP
Measured: Once every other week for 12 week study period
Neurological assessments via blood testing: serotonin, GABA and norepinephrine
Measured: Once every other week for the 12 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Heather Zwickey, National University of Natural Medicine
- Investigators
- Carol Marquez, MD, Principal investigator, Oregon Health and Science UniversityHeather Zwickey, PhD, Principal investigator, Helfgott Research Institute at National College of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691119
- Sponsor's protocol ID
- IRB00003439
- Status last verified
- May 2013
- First submitted
- 3 Jun 2008
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Relaxation and Visualization Therapy for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00691119
- Acronym / sponsor ID
- IRB00003439
- Conditions
- Breast Cancer
- Keywords
- breast cancer, radiation, Relaxation and Visualization Therapy, relaxation, visualization, RVT, complementary and alternative medicine, CAM
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Relaxation and Visualization TherapyRelaxation and Visualization Therapy group |
| B | Active comparator | Other: Health educationHealth education group |
| C | No intervention | –Control group |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women who have been diagnosed with breast cancer and have been referred to radiotherapy at OHSU
- between 45 and 70 years of age
Key exclusion criteria (8 listed)
- receiving chemotherapy concurrently
- uses tobacco products
- has a fear or aversion to blood draws
- has a history of hypertension
- uses recreational drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation and Visualization TherapyAlso: RVTTwenty 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. | Behavioural | A |
| Health educationFacilitated health education sessions, twenty minutes, five times a week for six weeks. | Other | B |
Primary outcome
Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy
Time frame: Ongoing
Time of onset, length, and severity of fatigue with the Schwartz Cancer Fatigue Scale (SCFS)
Time frame: Five days a week for six weeks
11 secondary outcomes
Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity scale
Time frame: Once a week for six weeks
Quality of Life [SF-36]
Time frame: Once during week 1, week 6 and week 12 of intervention
Perceived Stress Scale
Time frame: Once during week 1, week 6 and week 12 of intervention
State and Trait Anxiety Inventory[STAI]
Time frame: Once during week 1, week 6 and week 12 of intervention
Functional Assessment of Cancer Therapy-Breast [FACT-B]
Time frame: Once during week 1, week 6, and week 12 of intervention
Transformative Change Scale
Time frame: Once during week 1, week 6, and week 12 of intervention
Diet inquiry
Time frame: once during week 6 and week 12 of intervention
Heart rate monitoring
Time frame: Five days a week during six week intervention, once during final week 12 visit
Adverse events
Time frame: During radiation visits (five times a week for six weeks) with doctor/principal investigator, week 6 and week 12 visit
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
Neurological assessments via blood testing: serotonin, GABA and norepinephrine
Time frame: Once every other week for the 12 week study period
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Marquez, MD principal investigator
Oregon Health and Science University
Heather Zwickey, PhD principal investigator
Helfgott Research Institute at National College of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and Visualization Therapy and Health education in people with Breast Cancer, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish methodological feasibility for a larger study of RVT for women with breast cancer receiving radiotherapy (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.