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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: Clinical Trial NA study, sponsored by NYU Langone Health.
NCT03227744 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.
Interventions
- OTHER Surveys
- BEHAVIORAL Group therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-04-19 |
| Est. Completion | 2018-12-28 |
| Phase | NA |
Why NCT03227744 stopped before completion
NCT03227744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Surveys is the first listed.
NCT03227744 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03227744's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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