Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments

Study Overview
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Brief Summary
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The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).

Official Title
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A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Patient Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of metastatic prostatic adenocarcinoma Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy Able to complete written surveys in English Exclusion Criteria: More than 2 prior systemic treatment regimens utilized in addition to castration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention<br>Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires. | Behavioral: Patient Education<br>* Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.<br>|
| No Intervention: No Intervention<br>Participants that decline the education session will continue with routine care of their cancer. They will also be asked to complete questionnaires. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that undergo orchiectomy after receiving study education intervention |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that agree to participate in an educational session on surgical orchiectomy |  | 1 year | 
| Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status. |  | 1 year | 
| Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy. |  | 1 year | 
| Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy. |  | 1 year | 
| Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale. | Results of patient reported satisfaction regarding their decision to undergo orchiectomy will be reported based on responses to validated Decision Regret Scale questionnaire. Higher regret scores will be associated with dissatisfaction with the decision, lower regret scores will be associated with satisfaction regarding treatment decision. | 1 year | 
| Comparison of costs of medical versus surgical castration |  | 1 year |