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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
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Patient Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients that undergo orchiectomy after receiving study education intervention [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients that agree to participate in an educational session on surgical orchiectomy [ Time Frame: 1 year ]
  2. Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status. [ Time Frame: 1 year ]
  3. Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy. [ Time Frame: 1 year ]
  4. Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy. [ Time Frame: 1 year ]
  5. 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.

  6. Comparison of costs of medical versus surgical castration [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT04705038


Contacts
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Contact: Personalized Cancer Care Consortium 773.702.1220 PhaseIICRA@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medicine Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Clinical Trials Intake    855-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Walter Stadler, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Study Chair: Walter Stadler, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04705038    
Other Study ID Numbers: IRB20-0736
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases