PRISM: Patient Experiences With PET Imaging in Prostate Cancer
NCT Number: NCT06523777
Acronym: PRISM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Sponsor: Yale University
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2028-07
Locations: Radiology and Biomedical Imaging - New Haven - Smilow Cancer Hospital (North Pavilion):, New Haven, Connecticut, 06520, United States|Saint Raphael's Radiology and Biomedical Imaging, Basement Location., New Haven, Connecticut, 06520, United States

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.

Primary Outcome Measures: Change in Memorial Anxiety Scale for Prostate Cancer (MAX-PC), An 18-item instrument assessing frequency of anxiety in response to prostate cancer with 4 Likert responses ranging from 0 (not at all) to 3 (often); total score range 0 to 54). Higher scores indicate more anxiety., baseline, 3-6 months, and 12 months|Change in Decisional Conflict Scale (DCS), A 16-item instrument using a 5-point Likert scale, ranging from 0 (strongly agree)-4 (strongly disagree), that has been widely applied to understand decision-making in prostate cancer. Higher scores indicate greater degrees of decisional conflict. DCS subscales include patient perceptions of uncertainty in choosing among treatment options, the contribution of modifiable factors (e.g., feeling uninformed), and effectiveness of decision-making (e.g., satisfaction with the choice). Total and subscale scores range from 0 to 100., baseline, 3-6 months, and 12 months|Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26), A 26 item prostate cancer specific health-related quality of life (HRQOL) questionnaire assessing urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL., baseline, 3-6 months, and 12 months|Change in EuroQol-5 Dimension (EQ-5D), The instrument assesses five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D values can be converted to calculate health utilities that will be used for estimation of quality adjusted life years in decision analytic modeling. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales., baseline, 3-6 months, and 12 months
Secondary Outcome Measures: Qualitative interviews on patient experiences and perspectives on PET imaging., Longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging to assess emergent themes. A subset of patients will be invited to participate in parallel in depth focused interviews occurring at three time points matching those of the surveys. Sample size will be dynamic and assessed based on emergent themes that become apparent during coding and analysis of interviews., baseline, 3-6 months, and 12 months