Clinical trial NCT03227744: A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
Official title: A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Anxiety
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 26
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of MAX-PC Scores
timeFrame: Change from baseline to 4 weeks to 12 weeks
measure: Assessment of FACT-P Scores
timeFrame: Change from baseline to 4 weeks to 12 weeks
Secondary outcomes:
measure: Assessment of anxiety scores as a function of time
timeFrame: Change from baseline to 4 weeks to 12 weeks
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: NYU Winthrop Hospital
name: Aaron Pinkhasov, MD
role: PRINCIPAL_INVESTIGATOR
References: