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

NCT03227744 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-02-06

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Group therapy

Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.

OTHER

Surveys

MAX-PC, GAD and FACT-P

Sponsors & Collaborators

Principal Investigators

  • Aaron Pinkhasov, MD · NYU Winthrop Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2018-12-28
Completion
2018-12-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227744 on ClinicalTrials.gov