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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

∙ 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.

∙ 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.

Locations
United States
California
San Francisco Veterans Affairs Medical Center
RECRUITING
San Francisco
Contact Information
Primary
Marissa McPhaul
Marissa.McPhaul@ucsf.edu
877-827-3222
Time Frame
Start Date: 2022-05-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 250
Treatments
Experimental: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers
Patient participants will be instructed to install a mobile app to record their medical appointment, which research staff will use to analyze patient-provider communication. All participants will undergo semi-structured interviews and/or focus groups. Post appointment follow-up with surveys and assessments regarding knowledge of disease information, quality of life, and other measures will be administered after the provider-patient appointment.
Experimental: Stage 3: Patients, Caregivers using developed GA platform
About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid GA platform preference delivery (online, print, or both online and print), review the GA online platform, and possibly undergo consultation and training for audio recording of the scheduled appointment. Patients and caregivers attend the scheduled germline testing appointment on day 1. Patients complete surveys and patients and caregivers may complete an interview on study. Providers participate in focus groups and complete surveys on study.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: United States Department of Defense

This content was sourced from clinicaltrials.gov