PRISM: Patient Experiences With PET Imaging in Prostate Cancer

Clinicaltrials.gov ID: NCT06523777
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 300

Conditions

Prostate Cancer

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 patient’s medical record (EPIC).

Locations

5 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Michael Leapman, MD

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Michael Leapman, MD

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Michael Leapman, MD

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Michael Leapman, MD

Status

  • RECRUITING

Central Contacts

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)

Time Frame: baseline, 3-6 months, and 12 months

Change in Decisional Conflict Scale (DCS)

Time Frame: baseline, 3-6 months, and 12 months

Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)

Time Frame: baseline, 3-6 months, and 12 months

Change in EuroQol-5 Dimension (EQ-5D)

Time Frame: baseline, 3-6 months, and 12 months

Secondary Outcome Measures

Qualitative interviews on patient experiences and perspectives on PET imaging.

Time Frame: baseline, 3-6 months, and 12 months

Timeline

  • Last Updated
    November 4, 2024
  • Start Date
    July 26, 2024
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    July 1, 2028

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