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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03227744
Recruitment Status : Terminated (Study has been terminated)
First Posted : July 24, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Group therapy Other: Surveys Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : December 28, 2018
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227744


Locations
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United States, New York
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
New York University School of Medicine
Investigators
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Principal Investigator: Aaron Pinkhasov, MD NYU Winthrop Hospital
  Study Documents (Full-Text)

Documents provided by New York University School of Medicine:
Study Protocol  [PDF] February 24, 2017
Informed Consent Form  [PDF] May 2, 2017


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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03227744     History of Changes
Other Study ID Numbers: 17314
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Prostate Cancer, Anxiety

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases