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Two-Stage Consent and Mindfulness for Prostate Cancer Screening

N/A
Waitlist Available
Led By Behrar Ehdaie, MD, MPH
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new way of doing clinical trials, called two-stage consent. In this design, patients are first asked if they are okay with their routine clinical data being used for research. If they agree, they are then randomly selected to be offered an intervention that may improve their experience of a prostate biopsy. Only patients who are randomized to the experimental arm are informed about the benefits and risks of the intervention and are asked to sign a second consent form. There are two separate randomizations in this study: one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.

Who is the study for?
This trial is for English-speaking male patients scheduled for a standard prostate needle biopsy under local anesthesia. It's open to those having their first, repeat, or active surveillance biopsy and who may consent to a mind-body intervention study within the next year. Men with prior rectal surgery or anal strictures needing surgical intervention before biopsy, or previous prostate radiation are excluded.Check my eligibility
What is being tested?
The study tests a two-stage consent process in clinical trials and evaluates a brief mind-body guided imagery exercise aimed at reducing procedural pain during prostate biopsies. Patients will be randomly chosen either for usual informed consent (one-stage) or an experimental two-stage consent; and separately randomized again to receive either the mindfulness intervention or no additional treatment (control).See study design
What are the potential side effects?
Since this trial involves meditation as an intervention, there are minimal expected side effects compared to medical treatments. However, some individuals might experience discomfort from sitting still during meditation sessions or emotional distress if past traumas surface.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients who sign consent form

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + MeditationExperimental Treatment3 Interventions
Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Group II: Usual Care GroupActive Control2 Interventions
Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meditation
2021
Completed Phase 3
~2740
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,230 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,684 Patients Enrolled for Prostate Cancer
Behrar Ehdaie, MD, MPHPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Prostate Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT03507725 — N/A
Prostate Cancer Research Study Groups: Usual Care Group, Usual Care + Meditation
Prostate Cancer Clinical Trial 2023: Prostate Biopsy Highlights & Side Effects. Trial Name: NCT03507725 — N/A
Prostate Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03507725 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this trial?

"Unfortunately, this clinical trial is not currently enrolling patients. Originally posted on April 11th 2018 and last updated October 25th 2022; although the study itself has closed its doors to new participants, there are 1322 other trials actively recruiting volunteers at the present moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Staged Consent Before Prostate Biopsy
2018. "Early Staged Consent Before Prostate Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03507725.
~56 spots leftby Apr 2025
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