Back to resultsEffect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Education
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility 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.
Sites / Locations
- University of Chicago Medicine Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Intervention
No Intervention
Arm Description
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
Participants that decline the education session will continue with routine care of their cancer. They will also be asked to complete questionnaires.
Outcomes
Primary Outcome Measures
Number of patients that undergo orchiectomy after receiving study education intervention
Secondary Outcome Measures
Number of patients that agree to participate in an educational session on surgical orchiectomy
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
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.
Comparison of costs of medical versus surgical castration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04705038
Brief Title
Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
Official Title
A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Participants that decline the education session will continue with routine care of their cancer.
They will also be asked to complete questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Intervention Description
Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.
Primary Outcome Measure Information:
Title
Number of patients that undergo orchiectomy after receiving study education intervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of patients that agree to participate in an educational session on surgical orchiectomy
Time Frame
1 year
Title
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
Time Frame
1 year
Title
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
Time Frame
1 year
Title
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
Time Frame
1 year
Title
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
Description
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.
Time Frame
1 year
Title
Comparison of costs of medical versus surgical castration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Personalized Cancer Care Consortium
Phone
773.702.1220
Email
PhaseIICRA@medicine.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Stadler, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Intake
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Walter Stadler, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
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