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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-04-19 |
| Est. Completion | 2018-12-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗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.
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