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Questionnaires for Mammogram

N/A
Waitlist Available
Led By Lorenzo Cohen, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 minute intervals throughout the sbb procedure
Awards & highlights

Study Summary

This trial will test whether relaxation programs can help ease anxiety and pain during breast biopsy procedures. It will also look at whether these programs change brain activity, heart rate, or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 minute intervals throughout the sbb procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 minute intervals throughout the sbb procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
Secondary outcome measures
Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
General disorders and administration site conditions
6%
Cardiac disorders
6%
Nervous system disorders
6%
Investigations
6%
Gastrointestinal disorders
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Infections and infestations
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Guided Meditation Group (GM)Experimental Treatment4 Interventions
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.
Group II: Focused Breathing Group (FB)Active Control4 Interventions
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..
Group III: Standard of Care Group (SC)Active Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroencephalogram
2012
N/A
~90
Heart Rate
2012
N/A
~180
Questionnaires
2013
Completed Phase 2
~3030
Meditation
2021
Completed Phase 3
~2740

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,833 Total Patients Enrolled
Lorenzo Cohen, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
10 Previous Clinical Trials
1,746 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
2012. "Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03023215.
~7 spots leftby Apr 2025
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