Early Staged Consent Before Prostate Biopsy

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Behavioral: Questionnaires
Behavioral: Meditation
Procedure: Prostate Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT03507725
18-189

Details and patient eligibility

About

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.

Enrollment

390 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All male patients that will be scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia and potentially consented to the mindfulness study of mind-body intervention for prostate biopsy within the next 12 months.
  • English fluent

Exclusion criteria

  • Patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy.
  • Prior prostate radiation

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

390 participants in 2 patient groups

Usual Care + Meditation
Experimental group
Description:
Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Treatment:
Procedure: Prostate Biopsy
Behavioral: Meditation
Behavioral: Questionnaires
Usual Care Group
Active Comparator group
Description:
Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room
Treatment:
Procedure: Prostate Biopsy
Behavioral: Questionnaires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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