A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance
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|ClinicalTrials.gov Identifier: NCT03227744|
Recruitment Status : Terminated (Study has been terminated)
First Posted : July 24, 2017
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Group therapy Other: Surveys||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|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|
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.
MAX-PC, GAD and FACT-P
Placebo Comparator: Not enrolled in group therapy
Patients in control arm will be issued surveys
MAX-PC, GAD and FACT-P
- 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.
- 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.
- 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.
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
|United States, New York|
|NYU Winthrop Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Aaron Pinkhasov, MD||NYU Winthrop Hospital|