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

NCT04705038 | Completed

• 1 other identifier: IRB20-0736
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients that undergo orchiectomy after receiving study education intervention

  1 year

Secondary Outcomes (6)

• 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.

  1 year

Study Arms (2)

Educational Intervention

EXPERIMENTAL

Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.

Behavioral: Patient Education

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.

Interventions

Patient Education BEHAVIORAL

Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.

Educational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• More than 2 prior systemic treatment regimens utilized in addition to castration.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nabiel Mir, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 12, 2021
• Study Start: December 18, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)