Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523777
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
PRISM Patient Experiences With PET Imaging in Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Prostate Cancer Care Integrating Risks Benefits and Patient Experiences in the New Era of Molecular Imaging
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM
Brief Summary:
The purpose of this study is to examine patient experiences health-related quality of life and decision-making associated with PET imaging for prostate cancer In particular Prostate Specific Membrane Antigen PSMA PET a new and more sensitive form of imaging that can help identify metastatic cancer earlier and more reliably
Detailed Description:
The primary objective is to measure health related quality of life among patients with prostate cancer who are undergoing prostate specific membrane positron emission tomography PSMA-PET imaging This will be assessed in four domains cancer related anxiety decisional conflict health related quality of life physical functioning and health preferences
The secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging
Study Design Investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases In the first phase serial quantitative psychological anxiety uncertainty and HRQoL survey data from patients undergoing PET imaging in routine clinical care will be collected In the second phase a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging
Patient clinical and sociodemographic data will be collected through automated extraction from the medical record EPIC into the REDcap database through collaboration with JDAT For fields that are not populated via automated methods we will manually enter information via abstraction of the patients medical record EPIC
The secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging
Study Design Investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases In the first phase serial quantitative psychological anxiety uncertainty and HRQoL survey data from patients undergoing PET imaging in routine clinical care will be collected In the second phase a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging
Patient clinical and sociodemographic data will be collected through automated extraction from the medical record EPIC into the REDcap database through collaboration with JDAT For fields that are not populated via automated methods we will manually enter information via abstraction of the patients medical record EPIC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None