Questionnaires for Meditation for Breast Biopsy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
Meditation for Breast Biopsy
Questionnaires - Behavioral
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether guided relaxation programs can reduce anxiety and pain during breast biopsy.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Questionnaires will improve 1 primary outcome and 1 secondary outcome in patients with Meditation for Breast Biopsy. Measurement will happen over the course of 1 day.

1 day
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
3-5 minute intervals throughout the SBB procedure
Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Standard of Care Group (SC)
1 of 3
Focused Breathing Group (FB)
1 of 3
Guided Meditation Group (GM)
1 of 3
Active Control
Experimental Treatment

This trial requires 84 total participants across 3 different treatment groups

This trial involves 3 different treatments. Questionnaires is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Guided Meditation Group (GM)Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention. Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB. Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Standard of Care Group (SC)Participants listen to a 10 minute neutral-content audio clip from National Public Radio prior to stereotactic breast biopsy (SBB). Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB. Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Focused Breathing Group (FB)Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention. Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB. Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB..
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~2510
Meditation
2018
Completed Phase 3
~4110
Heart Rate
2017
N/A
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-5 minute intervals throughout the sbb procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3-5 minute intervals throughout the sbb procedure for reporting.

Closest Location

University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
Women must be right hand dominant.
Women must be 18 years or older.

Patient Q&A Section

What causes meditation for breast biopsy?

"There are many aspects that play a role in an individual's decision to meditate for breast biopsy, which include psychological and sociocultural factors. Understanding these factors may aid the radiologist with a better understanding of their patients' choices and thereby improve the quality of the breast biopsy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for meditation for breast biopsy?

"The common treatment for meditation for breast biopsy is meditation only. It consists in an individualized psychotherapy of a doctor, with the use of hypnosis, guided imagery, visualization, and relaxation techniques." - Anonymous Online Contributor

Unverified Answer

What are the signs of meditation for breast biopsy?

"This is the first time that the effect of yoga-meditation on [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and breast biopsy have been investigated. There were significant positive correlations between the intensity of the meditation and its effect on breast cancer and breast biopsy. This suggests the necessity of conducting a detailed trial with a large group of breast cancer and breast biopsy patients before adopting yoga (or meditation) for the purpose of breast cancer and/or breast biopsy." - Anonymous Online Contributor

Unverified Answer

What is meditation for breast biopsy?

"With careful consideration, and in close consultation with patients, it seems that practicing some form of meditation may help women deal with stress related to the procedure more effectively." - Anonymous Online Contributor

Unverified Answer

How many people get meditation for breast biopsy a year in the United States?

"There is insufficient evidence to make a firm recommendation for or against the use of meditation to reduce adverse effects or improve satisfaction in Bx-Med. In addition to the low likelihoods of benefit, there is also concern by participants in this study about a potential for harm to their health and well-being. Further research is needed." - Anonymous Online Contributor

Unverified Answer

Can meditation for breast biopsy be cured?

"All patients with a successful outcome after biopsy who had a strong desire to be free of breast pain did so during the course of their follow-up. This is different from the present results as a previous study in the same patients. Data from a recent study obtained in the present study indicate that meditation is not a "cure" but a powerful help for the patients who need it." - Anonymous Online Contributor

Unverified Answer

How serious can meditation for breast biopsy be?

"Most patients reported that they could tolerate the procedure well. Only 5% were absolutely averse to breast biopsy. The procedure itself is not dangerous by itself. However, only a small number of patients will be diagnosed with breast cancer in a two-week interval, and only a minority will return for two additional biopsies. Moreover, in a two-year time frame, only a small proportion will require further medical tests. However, the procedure can become uncomfortable. It is imperative that patients are adequately informed of the risk of the procedure, the benefits, and potential complications of breast biopsy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating meditation for breast biopsy?

"There were few studies for which a P <.001 was found with the mediation analysis model that demonstrated the effect of meditation therapy was significant on the rate of metastasis and the incidence of distant recurrence. Further research should focus on the pathogenesis of metastasis and distant recurrence, and should be conducted in an appropriate sample size." - Anonymous Online Contributor

Unverified Answer

Is questionnaires typically used in combination with any other treatments?

"The current studies showed the feasibility of use and effectiveness of EQ-B and FNEQ-R for patient and provider-administered questionnaires. They also demonstrated the effectiveness of combining both a patient and provider questionnaires and a brief intervention over only a nurse. Further studies that compare the effect of questionnaires with physical exams and procedures are needed." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in questionnaires for therapeutic use?

"There appears to be a continuing evolution of questionnaires. There are important issues here including the selection of the construct to be measured, the choice of instrument and response set, and the extent to which it is possible to measure change over time or from one instrument-generation to the next. The way questions are phrased, the way they are framed in surveys, and the way responses are coded and classified all have a profound effect on survey results. As a result, caution must be exercised in attempting to compare QOL results across different questionnaires when the same or similar measures are being employed. There also remains some uncertainty about the appropriate method of analysis and the appropriateness of conducting psychometric analyses." - Anonymous Online Contributor

Unverified Answer

What is questionnaires?

"More research is needed about the specific use of questionnaires as tool of screening and patient education, because there is not a clear definition about their use. A large group of clinicians use questionnaires to screen patients. One major use of questionnaires is to detect and to give information about the [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). A large group of breast specialists or surgeon use the same questionnaires to evaluate and inform the patients about the options for surgical treatment of breast cancers. It is important to get the input of experts in other groups, in particular in the fields of primary care, because questionnaires are not a perfect evaluation tool, because they do not make it obvious when patients need more information and when they need more medical follow-ups." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets meditation for breast biopsy?

"Breast cancer is the 4th most common cancer in the United States. About 1 in 3 patients who present with an imaging examination for an mammographically detected breast mass have a breast cancer within it. [Meditation for breast biopsy]. A 2014 study found that the average age someone gets meditation for breast biopsy was 62.3 years, with the youngest at 20 and the oldest at 81. The average age for first mammography appointment in the 2014 study was 50.1 years. The 2014 study found that there was a significant correlation between the two, but a different 2014 study found that age of first diagnosis differs considerably depending on the type of cancer. About 20% of breast cancer patients were detected due to a symptom." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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