Early Staged Consent Before Prostate Biopsy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/5/2019 |
| Start Date: | April 11, 2018 |
| End Date: | April 2020 |
| Contact: | Behfar Ehdaie, MD, MPH |
| Email: | ehdaieb@mskcc.org |
| Phone: | 646-422-4406 |
A Brief Mind-body Intervention to Reduce Pain and Anxiety During Prostate Needle Biopsy: a Randomized Controlled Trial With Early Staged Consent
There is a fundamental need for novel study designs that can improve patient understanding
during informed consent, encourage
This is a pilot 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 design,
patients will first be approach 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.
during informed consent, encourage
This is a pilot 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 design,
patients will first be approach 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.
Inclusion Criteria:
- All male patients (all ages) scheduled for standard prostate needle biopsy (first,
repeat or active surveillance biopsy) under local anesthesia will be eligible for the
study.
Exclusion Criteria:
- Patient with prior rectal surgery or anal stricture requiring surgical intervention
prior to biopsy.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Behfar Ehdaie, MD, MPH
Phone: 646-422-4406
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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