Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171139
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-12-06
Brief Title:
Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing TGT counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation
Detailed Description:
PRIMARY OBJECTIVES
Stage 1 To evaluate education quality of the intervention in Black or African American men with prostate cancer
Stage 2 To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer
SECONDARY OBJECTIVES
Stage 1
1 To evaluate completeness of the intervention content
2 To identify barriers and facilitators for using the intervention
Stage 2
1 To evaluate the acceptability of the intervention among Black or African American men with prostate cancer
2 To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer
3 To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer
4 To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer
5 To evaluate patient perspectives on the intervention
6 To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool
OUTLINE
This is a two-stage study In Stage 1 Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT or who have decided to undergo TGT or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days The investigators will then refine the tool to be piloted in Stage 2
Stage 2 A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool and answer questionnaires about the tool
Stage 1 To evaluate education quality of the intervention in Black or African American men with prostate cancer
Stage 2 To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer
SECONDARY OBJECTIVES
Stage 1
1 To evaluate completeness of the intervention content
2 To identify barriers and facilitators for using the intervention
Stage 2
1 To evaluate the acceptability of the intervention among Black or African American men with prostate cancer
2 To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer
3 To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer
4 To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer
5 To evaluate patient perspectives on the intervention
6 To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool
OUTLINE
This is a two-stage study In Stage 1 Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT or who have decided to undergo TGT or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days The investigators will then refine the tool to be piloted in Stage 2
Stage 2 A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool and answer questionnaires about the tool
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10339 | OTHER | NCI Clinical Trials Reporting Program CTRP | None |