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Stage 1: Tool Development for Prostate Cancer

N/A

Recruiting

Led By Daniel Kwon, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage 1: Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.

Stage 1: Fluent in English (reading, writing, and speaking)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

Study Summary

This trial will test a tool to make genetic testing for prostate cancer more fair and accessible for Black men with advanced prostate cancer.

Who is the study for?

This trial is specifically for Black or African-American men who have metastatic prostate cancer. It aims to improve the process of counseling before genetic testing related to their cancer.Check my eligibility

What is being tested?

The study is evaluating a new counseling tool designed for pre-tumor genomic testing in these patients. Participants will be asked to complete questionnaires as part of the assessment.See study design

What are the potential side effects?

Since this trial involves questionnaires and a counseling tool, there are no direct medical side effects associated with typical drug interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prostate cancer that has spread to other parts of my body.

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I am fluent in English for reading, writing, and speaking.

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I am 18 years old or older.

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I am 18 years old or older.

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I am fluent in English for reading, writing, and speaking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of participant responses (Stage 1)

Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)

Proportion of enrolled participants (Stage 2)

+1 more

Secondary outcome measures

Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)

Mean score of cancer genomic testing knowledge (Stage 2)

Mean score of investigator-developed, measure of acceptability items (Stage 2)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage 1: Tool Implementation (Pilot Study)Experimental Treatment2 Interventions

Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.

Group II: Stage 1: Tool DevelopmentExperimental Treatment2 Interventions

Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,511 Previous Clinical Trials

15,243,679 Total Patients Enrolled

51 Trials studying Prostate Cancer

16,953 Patients Enrolled for Prostate Cancer

Prostate Cancer FoundationOTHER

47 Previous Clinical Trials

2,700 Total Patients Enrolled

27 Trials studying Prostate Cancer

1,850 Patients Enrolled for Prostate Cancer

Daniel Kwon, MDPrincipal InvestigatorUniversity of California, San Francisco

4 Previous Clinical Trials

568 Total Patients Enrolled

3 Trials studying Prostate Cancer

541 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up to be a part of this research experiment?

"Affirmative. Clinicaltrials.gov reveals that this experiment is currently looking for volunteers, as it was first posted on December 1st 2023 and most recently updated on the 6th of December 2023. The trial requires 80 patients to be enrolled from one single medical facility."

Answered by AI

Are there any remaining vacancies available for participants in this experiment?

"Affirmative. Clinicaltrials.gov hints that this clinical trial, which was first announced on December 1st 2023, is actively enrolling participants. 80 volunteers must be recruited from a single location for the study to move forward."

Answered by AI

What is the ultimate goal of this experimental endeavor?

"Within a two-month period, this clinical trial will analyse the frequency of participant responses (Stage 1) and other secondary outcomes such as: The proportion of participants who have received pre-test counseling tool for tumor genetics before undergoing TGT examination through medical record review (Stage 2), Mean score from Acceptability of Intervention Measurement on a 5 point scale based on agreement with statement given by clinician (Stage 2), and mean scores from investigator developed measure to assess acceptability also scored between 1 - 5 depending on level of accord."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer

2023. "Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171139.