RECRUITING

Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

Official Title

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

Quick Facts

Study Start:2022-05-12

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05396872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 1. Participated in Stage 1. 2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver). 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. 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. 2. Able to understand study procedures and to comply with them for the entire length of the study. 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. 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. 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. 1. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible. 2. If they do not meet any of the inclusion criteria above. 1. Participants who do not meet the inclusion criteria above. 1. Prior receipt of germline testing. 2. Prior participation in Stage 1 for germline testing. 1. If they do not meet any of the inclusion criteria above.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

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.
1. Participated in Stage 1.
2. Partner, family-member, or friend of a Stage 2 participant (identified by the patient-participant as a caregiver).
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.
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.
2. Able to understand study procedures and to comply with them for the entire length of the study.
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.
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.
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.
1. For patient-participants undergoing genetic testing, if results of the genetic tests have already been disclosed to the participant, they are not eligible.
2. If they do not meet any of the inclusion criteria above.
1. Participants who do not meet the inclusion criteria above.
1. Prior receipt of germline testing.
2. Prior participation in Stage 1 for germline testing.
1. If they do not meet any of the inclusion criteria above.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Marissa McPhaul

CONTACT

877-827-3222

Marissa.McPhaul@ucsf.edu

Principal Investigator

Daniel Kwon, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Daniel Kwon, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-12

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-05-12

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Informed Decision-Making
Precision Oncology
Military Veterans
Germline Testing
Somatic Testing
Targeted Therapy
Genetic Testing

Additional Relevant MeSH Terms

Prostate Cancer
Advanced Prostate Carcinoma