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NCT03227744 · ClinicalTrials.gov registry record · NA

A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance

A NA study, sponsored by NYU Langone Health.

Terminated
Registry status
NA
Development phase
26
Enrollment target

NCT03227744 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 26 participants.

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The verdict

NCT03227744, a NA study, was terminated before completion, sponsored by NYU Langone Health.

TERMINATED
Registry status
NA
Development phase
26 participants
Enrollment target

Study Summary

This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to further our understanding of anxiety in men who have been diagnosed with prostate cancer and are undergoing Active Surveillance. Men who have elected Active Surveillance for their management of prostate cancer are eligible to participate in this study. After signing informed consent, all participants will complete two brief questionnaires (The Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] and the General Anxiety and Depression Scale 7 \[GAD-7\] to measure their anxiety levels. If the participant scores above a certain number, they will be asked to participate in the study. Patients will be randomly assigned to either a control group, who will receive no treatment, but continue to follow up with their urologist to manage their prostate cancer as usual, or the treatment group. The treatment group will receive 12 one-hour group therapy sessions that will take place once a week for 12 weeks with a licensed psychologist free of charge. They will be instructed to follow up with their urologist as previously determined for their prostate cancer management. Patients in both groups will be monitored for anxiety completing three questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If patients require further therapy beyond the group treatment sessions, the investigators may refer them to a psychologist or psychiatrist for further treatment.

Interventions

  • OTHER Surveys
  • BEHAVIORAL Group therapy

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2017-04-19
Est. Completion 2018-12-28
Phase NA

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT03227744

The ClinicalTrials.gov registry entry for NCT03227744 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Surveys is the first listed.

NCT03227744 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03227744 about?

NCT03227744 is a clinical study titled "A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance". This study is a clinical trial to determine whether a 12-week group therapy intervention for patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal of the study is to furthe...

What is the current status of trial NCT03227744?

This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2017-04-19. Estimated completion is 2018-12-28.

What interventions are being tested in trial NCT03227744?

The interventions under investigation include: Surveys (OTHER), Group therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT03227744?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.