Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Daniel Kwon, MD (ucsf)
Headshot of Daniel Kwon
Daniel Kwon

Description

Summary

This project proposes to understand and improve Veterans' decision-making in precision oncology (germline testing, somatic tumor testing, and targeted therapy) for advanced prostate cancer. As precision oncology expands, a comprehensive strategy to support patient informed decision- making (IDM) has not been developed.

Official Title

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

Details

PRIMARY OBJECTIVES: Stage 1: To evaluate patient-participants' decisional conflict about precision oncology. Stage 2: To develop a Decision Support Intervention (DSI) to improve decision-making about precision oncology SECONDARY OBJECTIVES: Stage 1: 1. To evaluate patient-participants' precision oncology knowledge 2. To evaluate patient-participants' perceived shared decision-making effort 3. To evaluate the degree of decision support provided by provider-participants' during an appointment with the patient-participant. 4. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology 5. To evaluate patient-participants' decisional needs and to identify potential disparities about precision oncology from the perspective of the provider-participant. 6. To evaluate how many patient-participants receive precision oncology intervention or testing after having an appointment and discussion with a provider-participant Stage 2: 1. To describe the multi-stakeholder development process of the DSI Military Veterans with an upcoming hematology/oncology visit in which germline testing, somatic testing, or targeted therapy will be discussed. Decision-making for precision oncology will be characterized and their decisional needs assessed. Patients, caregivers, and physicians will participate in both Stage 1 and Stage 2, occurring in parallel. The investigators and stakeholders will then design and evaluate a DSI based on the results and feedback received in both stages.

Keywords

Prostate Cancer Advanced Prostate Carcinoma Informed Decision-Making Precision Oncology Military Veterans Germline Testing Somatic Testing Targeted Therapy Genetic Testing Prostatic Neoplasms Mobile app

Eligibility

For people ages 18 years and up

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:
  3. 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.
  4. 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:
  2. Principal investigator of a Precision Oncology Program for Cancer of the Prostate (POPCaP) site.
  3. 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.
  4. 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.

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

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

  1. 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.

Location

  • San Francisco Veterans Affairs Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientist at UC Cancer

  • Daniel Kwon, MD (ucsf)
    I am a physician-investigator. I care for patients with advanced cancer who are hospitalized and patients with genitourinary malignancies, such as prostate cancer. My research interests involve improving patient-centered outcomes for patients with cancer. This includes patient decision-making support, outcomes research, survivorship, cognition, and biomarkers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05396872
Study Type
Interventional
Participants
Expecting 117 study participants
Last Updated