Early Staged Consent Before Prostate Biopsy

NCT03507725 | Completed

• 1 other identifier: 18-189
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

mind-body intervention; 18-189

Outcome Measures

Primary Outcomes (1)

• number of patients who sign consent form

  2 years

Study Arms (2)

Usual Care + Meditation

EXPERIMENTAL

Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure

Behavioral: Meditation; Procedure: Prostate Biopsy; Behavioral: Questionnaires

Usual Care Group

ACTIVE COMPARATOR

Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room

Procedure: Prostate Biopsy; Behavioral: Questionnaires

Interventions

Meditation BEHAVIORAL

The brief mind-body intervention, specifically developed for this study, is a combination of "mindfulness meditation" with a specific cognitive component of "guided imagery". Patient intervention, they will be given headphones connected to an MP4 player in the clinic area to listen to a pre-biopsy mindfulness exercise (10 minutes). They will then be brought into the biopsy procedure room and given a second set of headphones, guiding the patient through the mindfulness intervention during the biopsy procedure (10 minutes).

Usual Care + Meditation

Prostate Biopsy PROCEDURE

Prostate needle biopsy under local anesthesia

Usual Care + Meditation; Usual Care Group

Questionnaires BEHAVIORAL

Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.

Usual Care + Meditation; Usual Care Group

Eligibility Criteria

• Gender Eligibility Details: Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Meditation; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Behrar Ehdaie, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: April 25, 2018
• Study Start: April 11, 2018
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (1)