Improving decision-making about precision oncology for veterans with advanced prostate cancer

A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer

This study is trying to help veterans with advanced prostate cancer make better decisions about precision oncology tests and treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05396872 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to enhance informed decision-making regarding precision oncology tests among veterans diagnosed with advanced prostate cancer. The study will evaluate patients' decisional conflict and develop a Decision Support Intervention (DSI) to facilitate better decision-making. It will also assess the knowledge of precision oncology among participants and the effectiveness of provider support during consultations. The ultimate goal is to reduce disparities in genetic testing and increase participation in precision oncology trials.

Who should consider this trial

Good fit: Ideal candidates include veterans aged 18 and older with locally advanced, metastatic, or castration-resistant prostate cancer who are scheduled for a hematology/oncology appointment.

Not a fit: Patients who do not speak or understand English or those without a diagnosis of advanced prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could empower veterans with advanced prostate cancer to make more informed decisions about their treatment options.

How similar studies have performed: Other studies have shown success in improving decision-making through similar interventions, indicating potential for positive outcomes in this approach.

Eligibility criteria

Stage 1: Inclusion Criteria

Patient-participants:

1. Age 18 years or older.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Able to understand a written informed consent document and willing to sign it.
4. Able to speak, read, and understand English.
5. Documentation of locally advanced (pelvic lymph node-positive), metastatic, or castration-resistant prostate cancer in a clinical progress note or pathology report.
6. 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:

1. Age 18 years or older.
2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interviews.
3. Able to provide verbal consent.
4. Able to speak and understand English.

Provider-participants:

1. Hematology/oncology or Genetics provider (medical doctor (MD) or nurse practitioner (NP), post-first year clinical fellows allowed).
2. 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.
3. Able to provide consent via email.

Stage 2: Inclusion Criteria:

Patient participants:

1. Participated in Stage 1.
2. Completed either germline or tumor testing for prostate cancer.
3. Able to understand study procedures and to comply with them for the entire length of the study.

Caregiver-participants:

1. Participated in Stage 1.
2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).

SFVAHCS Provider-participants:

1. Participated in Stage 1.
2. 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:

1. 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.
2. Able to understand study procedures and to comply with them for the entire length of the study.

Stage 3: Inclusion Criteria

Patient-participants

1. Age 18 years or older.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Able to understand a written informed consent document and willing to sign it.
4. Able to speak, read, and understand English.
5. 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.
6. Scheduled to attend a hematology/oncology appointment (in person or remote) during which provider anticipates discussing germline testing.

Caregiver-participants

1. Age 18 years or older.
2. Identified by a patient-participant as an individual who is involved with the patient's care, and willing to join the interview.
3. Able to provide verbal consent.
4. Able to speak and understand English.

Provider-participants

1. SFVAHCS physician (MD) trained in medical oncology or undergoing training as a clinical fellow.
2. 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.
3. Able to provide verbal consent.

Stage 1: Exclusion Criteria

Patient-participants:

1. 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
2. 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:

1. Prior receipt of germline testing.
2. Prior participation in Stage 1 for germline testing.

Caregiver and Provider-Participants

1\. If they do not meet any of the inclusion criteria above.

Where this trial is running

San Francisco, California

• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Daniel Kwon, MD — University of California, San Francisco
• Study coordinator: UCSF Genitourinary Medical Oncology Recruitment

Conditions Prostate Cancer; Advanced Prostate Carcinoma; Informed Decision-Making; Precision Oncology; Military Veterans; Germline Testing; Somatic Testing; Targeted Therapy