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

Clinicaltrials.gov ID: NCT04705038
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 100

Conditions

Prostate Cancer

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).

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Study Chair

  • Walter Stadler, MD

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.

Study Plan

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

    Description:

    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.nnThey will also be asked to complete questionnaires.

Outcome Measures

Primary Outcome Measures

Number of patients that undergo orchiectomy after receiving study education intervention

Time Frame: 1 year

Secondary Outcome Measures

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

Comparison of costs of medical versus surgical castration

Time Frame: 1 year

Timeline

  • Last Updated
    July 31, 2024
  • Start Date
    January 12, 2021
  • Today
    June 1, 2025
  • Completion Date ( Estimated )
    December 1, 2025

Similar Trials

light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people All Ages