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NCT03507725 · ClinicalTrials.gov registry record · NA
Early Staged Consent Before Prostate Biopsy
A NA study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 390
- Enrollment target
NCT03507725: Completed NA study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03507725 is a NA study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 390 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03507725, a NA study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 390 participants
- Enrollment target
Study Summary
This is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. The investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for procedural pain at the time of prostate biopsy. In the two-stage design, patients will first be approached for consent to 1) have their routinely collected clinical data used for research purposes and 2) be randomly selected to be offered an intervention to improve the experience of prostate biopsy. Only patients randomized to the experimental arm will be informed about the benefits and harms of the intervention and will sign a second consent for the experimental treatment. There will be two separate randomizations in this study, one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.
Interventions
- BEHAVIORAL Questionnaires
- BEHAVIORAL Meditation
- PROCEDURE Prostate Biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2018-04-11 |
| Est. Completion | 2024-10-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03507725
The ClinicalTrials.gov registry entry for NCT03507725 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Questionnaires is the first listed.
NCT03507725 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03507725 about?
NCT03507725 is a clinical study titled "Early Staged Consent Before Prostate Biopsy". This is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. The investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for proce...
What is the current status of trial NCT03507725?
This trial is currently completed. It is a NA study. The enrollment target is 390 participants. The study started on 2018-04-11. Estimated completion is 2024-10-14.
What interventions are being tested in trial NCT03507725?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Meditation (BEHAVIORAL), Prostate Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03507725?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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