Status:
RECRUITING
Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Advanced Prostate Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where i...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate patient-participants' decisional conflict about precision oncology. (Stage I) II. To develop a Decision Support Intervention (DSI) to improve decision-making about...
Eligibility Criteria
Inclusion
- Stage 1: Inclusion Criteria
- Patient-participants:
- Age 18 years or older.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written informed consent document and willing to sign it.
- Able to speak, read, and understand English.
- Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
- Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing, somatic tumor testing, or targeted therapy.
- Caregiver-participants:
- Age 18 years or older.
- Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.
- Able to provide verbal consent.
- Able to speak and understand English.
- Provider-participants:
- Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).
- Has discussed germline testing, somatic testing, or targeted therapy for an San Francisco Veteran Health Care System (SFVAHCS) patient with locally advanced or metastatic prostate cancer (as defined above) within the past 90 days of being contacted about the study.
- Able to provide consent via email.
- Stage 2: Inclusion Criteria:
- Patient participants:
- Participated in Stage 1.
- Completed either germline or tumor testing for prostate cancer.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Caregiver-participants:
- Participated in Stage 1.
- Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).
- SFVAHCS Provider-participants:
- Participated in Stage 1.
- Meets one of the two following criteria:
- Physician specializing in medical oncology (MD, post-first year clinical fellows allowed) who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.
- Non-SFVAHCS provider-participants:
- Meets one of the three following criteria:
- Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.
- Physician specializing in medical oncology who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 30 days of being contacted for this study.
- Physician specializing in genetics who has discussed genetic testing or targeted therapy with a patient with advanced prostate cancer within the past 90 days of being contacted for this study.
- Note: For Non-SFVAHCS providers, fellows are not eligible.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Stage 3: Inclusion Criteria
- Patient-participants
- Age 18 years or older.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written informed consent document and willing to sign it.
- Able to speak, read, and understand English.
- Documentation of high-risk localized, very high-risk localized, locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
- Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing.
- Caregiver-participants
- Age 18 years or older.
- Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interview.
- Able to provide verbal consent.
- Able to speak and understand English.
- Provider-participants
- SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow.
- Has discussed germline testing for prostate cancer with an SFVAHCS patient within the past year of being contacted about the study, or plans to discuss germline testing for prostate cancer with an SFVAHCS patient.
- Able to provide verbal consent.
- Stage 1: Exclusion Criteria
- Patient-participants:
- For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.
- Caregiver and Provider-Participants
- If they do not meet any of the inclusion criteria above.
- Stage 2: Exclusion Criteria
- 1\. Participants who do not meet the inclusion criteria above.
- Stage 3: Exclusion Criteria
- Patient-participants:
- Prior receipt of germline testing.
- Prior participation in Stage 1 for germline testing.
- Caregiver and Provider-Participants
- 1\. If they do not meet any of the inclusion criteria above.
Exclusion
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05396872
Start Date
May 12 2022
End Date
December 31 2027
Last Update
February 7 2025
Active Locations (1)
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1
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121