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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Group therapy
* Other: Surveys


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enrolled in group therapy<br>Patients in the group therapy arm will be enrolled in group therapy and be issued surveys. | Behavioral: Group therapy<br>* Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.<br>Other: Surveys<br>* MAX-PC, GAD and FACT-P<br>|
| Placebo Comparator: Not enrolled in group therapy<br>Patients in control arm will be issued surveys | Other: Surveys<br>* MAX-PC, GAD and FACT-P<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of MAX-PC Scores | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Anxiety