PRISM: Patient Experiences With PET Imaging in Prostate Cancer
Conditions
Prostate CancerSummary
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 patient’s medical record (EPIC).
Locations
5 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Michael S Leapman, MD
- 203-785-3128
- [email protected]
Principal Investigator
- Michael Leapman, MD
Status
- RECRUITING
Central Contacts
- Michael S Leapman, MD
- 203-785-3128
- [email protected]
Principal Investigator
- Michael Leapman, MD
Status
- RECRUITING
Central Contacts
- Michael S Leapman, MD
- 203-785-3128
- [email protected]
Principal Investigator
- Michael Leapman, MD
Status
- RECRUITING
Central Contacts
- Michael S Leapman, MD
- 203-785-3128
- [email protected]
Principal Investigator
- Michael Leapman, MD
Status
- RECRUITING
Central Contacts
- Michael S Leapman, MD
- 203-785-3128
- [email protected]
Principal Investigator
- Michael Leapman, MD
Eligibility Criteria
Inclusion Criteria:
* Documented diagnosis of prostate cancer
* Scheduled for their FIRST PSMA PET scan for prostate cancer
* English-speaking
* Willing and able to complete 4 surveys electronically or on paper at 3 timepoints (within 1 month after PET scan, 3-6 months, 12 months)
* Able to use mobile device (smartphone or tablet) or computer with web access to complete study surveys or able to complete paper surveys
Exclusion Criteria:
* Lack of access to a mobile device (smartphone or tablet) or computer with web access or unable to receive surveys by mail.
* Unable to give consent and be enrolled
* PET scan is being conducted within a clinical trial
Outcome Measures
Primary Outcome Measures
Change in Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Change in Decisional Conflict Scale (DCS)
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
Change in EuroQol-5 Dimension (EQ-5D)
Secondary Outcome Measures
Qualitative interviews on patient experiences and perspectives on PET imaging.
Timeline
Last Updated
November 4, 2024Start Date
July 26, 2024Today
January 23, 2025Completion Date ( Estimated )
July 1, 2028
Sponsors of this trial
Lead Sponsor
Yale UniversityCollaborating Sponsors
National Cancer Institute (NCI)