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



Status:Terminated
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:2/8/2019
Start Date:April 19, 2017
End Date:December 28, 2018

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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.


Inclusion Criteria:

- Age of 40

- Primary diagnosis of Prostate Cancer

- Initial MAX-PC score of ≥16.

- Sign a consent form allowing related information to be included in this research.

Exclusion Criteria:

- Prostate cancer is not their primary diagnosis.

- Have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic
medications (e.g., antidepressants, anxiolytics, mood stabilizers.)

- Have been diagnosed with cancer other than prostate cancer (and non-melanoma skin
cancer)

- Evidence of active substance abuse.

- Participants in the treatment group who are absent from more than 3 therapy sessions
will be excluded.
We found this trial at
1
site
259 1st Street
Mineola, New York 11501
Phone: 516-535-1900
?
mi
from
Mineola, NY
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