Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04705038|
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : February 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Patient Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Educational Intervention
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
Behavioral: Patient Education
Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.
No Intervention: No Intervention
Participants that decline the education session will continue with routine care of their cancer.
They will also be asked to complete questionnaires.
- Number of patients that undergo orchiectomy after receiving study education intervention [ Time Frame: 1 year ]
- Number of patients that agree to participate in an educational session on surgical orchiectomy [ Time Frame: 1 year ]
- Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status. [ Time Frame: 1 year ]
- Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy. [ Time Frame: 1 year ]
- Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy. [ Time Frame: 1 year ]
- Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale. [ Time Frame: 1 year ]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.
- Comparison of costs of medical versus surgical castration [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- More than 2 prior systemic treatment regimens utilized in addition to castration.
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): NCT04705038
|Contact: Personalized Cancer Care Consortium||773.702.1220||PhaseIICRA@medicine.bsd.uchicago.edu|
|United States, Illinois|
|University of Chicago Medicine Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Clinical Trials Intake 855-702-8222 firstname.lastname@example.org|
|Principal Investigator: Walter Stadler, MD|
|Study Chair:||Walter Stadler, MD||University of Chicago|
|Responsible Party:||University of Chicago|
|Other Study ID Numbers:||
|First Posted:||January 12, 2021 Key Record Dates|
|Last Update Posted:||February 9, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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