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

February 4, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enrolled in group therapy
Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.
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
Placebo Comparator: Not enrolled in group therapy
Patients in control arm will be issued surveys
Other: Surveys
MAX-PC, GAD and FACT-P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of MAX-PC Scores
Time Frame: Change from baseline to 4 weeks to 12 weeks
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.
Change from baseline to 4 weeks to 12 weeks
Assessment of FACT-P Scores
Time Frame: Change from baseline to 4 weeks to 12 weeks
Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
Change from baseline to 4 weeks to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of anxiety scores as a function of time
Time Frame: Change from baseline to 4 weeks to 12 weeks
In secondary analysis, a mixed effects model will be used when the outcome vector consists of all three measurements (baseline, 4 and 12 weeks) and via statistical contrasts will examine whether the relationship between PSA anxiety scores and time is linear or if the effect of intervention on anxiety scores is fully observed by week 4. Two-sided p-values ≤ 0.05 will be considered statistically significant.
Change from baseline to 4 weeks to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Aaron Pinkhasov, MD, NYU Winthrop Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

December 28, 2018

Study Completion (Actual)

December 28, 2018

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17314

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Group therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe