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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 90 days, 24 months
  • Procedures mentioned: Interviews, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate barriers, facilitators, and experiences of the patient-directed decision support intervention by conducting patient/caregiver-participant interviews. (Stage III) XVII."
  • "Patients also complete surveys and participate in interviews on study."
  • "Caregivers and providers also participate in interviews on study."
  • "STAGE II: Subset of SFVAHCS patients, caregivers, and providers who participated in stage I participate in an interview and may be asked to participate with an advisory board on study."
  • "Non-SFVAHCS providers participate in an interview on study."
  • "Patients complete surveys and patients and caregivers may complete an interview on study for up to 90 days post-appointment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at ways to help veterans with prostate cancer make informed choices about genetic tests used to guide cancer care. It includes veterans with advanced cancer and, in one stage, cancer that has not spread but is high risk. Caregivers and cancer care providers can also take part.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients in Stages 1 and 3 must be 18 or older, speak and read English, understand and follow study steps, and sign a consent form.
  • Stage 1 patients must have records showing prostate cancer that has spread to pelvic lymph nodes or other body parts, or keeps growing despite treatment to lower male hormones.
  • Stage 1 patients must have a cancer care visit planned to discuss inherited gene testing, tumor testing, or treatment aimed at specific cancer changes.
  • Stage 2 patients must have joined Stage 1, completed inherited gene or tumor testing, and be able to understand and follow study steps.
  • Stage 3 patients must have records showing high-risk or very high-risk cancer still in the prostate, or cancer as described for Stage 1. They must have a visit planned to discuss inherited gene testing.
  • Caregivers in Stages 1 and 3 must be 18 or older, help with the patient's care, agree to an interview, speak and understand English, and give spoken consent. Stage 2 caregivers must have joined Stage 1 and be named as a caregiver by a Stage 2 patient.
  • Stage 1 providers must be eligible cancer or genetics doctors, nurse practitioners, or fellows past their first training year. They must have discussed relevant testing or treatment with an eligible San Francisco VA patient within 90 days and agree by email. Stage 3 providers must be San Francisco VA cancer doctors or fellows who discussed inherited gene testing within the past year or plan to, and give spoken consent.
  • Stage 2 San Francisco VA providers must have joined Stage 1. Cancer doctors must have discussed testing or targeted treatment within 30 days; genetics doctors, within 90 days. Outside providers may qualify by these same time limits or by leading a POPCaP prostate cancer program site, and must understand and follow study steps.

Who can't join

  • Stage 1 patients having genetic testing cannot join if they have already been told their test results.
  • Stage 3 patients cannot join if they previously had inherited gene testing or took part in Stage 1 for inherited gene testing.
  • Stage 2 providers outside the San Francisco VA cannot be fellows, who are doctors getting more specialized training.
  • Stage 2 participants, and caregivers and providers in Stages 1 and 3, cannot join if they do not meet the requirements for their group.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA