- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07591701
Efforts to Increase Representation in Prostate Cancer Clinical Trials at Lyndon B. Johnson Hospital
Study Overview
Detailed Description
Primary Objectives:
The study objective is to increase the number of participants on prostate cancer clinical trials at LBJ. Investigators will complete several objectives:
- To design a culturally tailored video highlighting participant narratives and determine its impact on participants' decision-making pertaining to joining a clinical trial
- To conduct educational sessions with frontline oncology providers
- To coordinate participant care through utilization of a nurse navigator
- To evaluate the effectiveness of this multi-pronged intervention to increase enrollment onto two prostate cancer clinical trials and compare enrollment and one-year retention rates before and after the intervention
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Debanjan Pain, MD
- Phone Number: (713) 745-0075
- Email: dpain@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77090
- Recruiting
- The University of Texas M. D. Anderson Cancer Center
-
Contact:
- Debanjan Pain, MD
- Phone Number: 713-745-0075
- Email: dpain@mdanderson.org
-
Principal Investigator:
- Debanjan Pain, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
These criteria include diagnosed prostate cancer patients receiving care at LBJ Hospital who
Are eligible for an open prostate cancer clinical trial at LBJ Hospital during the study period
Can provide informed consent.
Exclusion Criteria:
These criteria include prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition or have a medical condition that prevents participation in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Intervention to Prostate Cancer Patient
The interventions will be conducted at Lyndon B. Johnson (LBJ) Hospital, a safety net facility that cares for a majority Latino and/or Black patient population.
|
Participants will watch a short video in clinic.
Participants will complete the two validated scales before and after viewing the video.
|
|
Experimental: To Conduct Educational Sessions with Frontline Oncology Providers
The investigator will conduct multiple one-hour educational sessions focused on participant-centered communication and cultural competency with the 42 oncology fellows during their academic half-days.
Fellows attending the educational sessions will be invited to complete a Likert-style course evaluation form and provide open-ended feedback."
|
Participants will watch a short video in clinic.
Participants will complete the two validated scales before and after viewing the video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Debanjan Pain, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Technology, Industry, and Agriculture
- Technology
- Tape Recording
- Audiovisual Aids
- Educational Technology
- Television
- Videotape Recording
Other Study ID Numbers
- 2025-1431
- NCI-2025-09179 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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