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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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: To evaluate patient-participants' precision oncology knowledge To evaluate patient-participants' perceived shared decision-making effort To evaluate the degree of decision support provided by provider-participants' during an appointment with the patient-participant. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology To evaluate patient-participants' decisional needs and to identify potential disparities about precision oncology from the perspective of the provider-participant. 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.

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

Conditions
-----------------
Prostate Cancer, Advanced Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Participant Surveys
* Other: Mobile app


Participation Criteria
=================
Eligibility Criteria
-----------------
Stage 1: Inclusion Criteria 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. Stage 2: Inclusion Criteria: 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. Stage 1: Exclusion Criteria Patient-participants: 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 & 2: Patients, Caregivers, Providers<br>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. | Other: Participant Surveys<br>* Online surveys administered post appointment<br>Other: Mobile app<br>* Mobile application installed on mobile device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score on the Decisional Conflict Scale (DCS) | The Decisional Conflict Scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scoring and interpretation Items are given a score value ranging from 0 = 'strongly disagree' to 4 = 'strongly agree'. Total Scores are a sum of the scores of the 16 items and are scaled by divided by 16 and then multiplied by 25 for a total scale score range from 0 [extremely high decisional conflict] to 100 [no decisional conflict]. Mean score and 95% confidence interval (CI) of the total DCS as well as the 4 subscales will be calculated. | 6 months | 
| Proportion of participants with a total score of >37.5 on the DCS | Participants who completed the DCS will be divided by their total score into those who scored >37.5 or not. The proportion of participants with a total score of > 37.5 will be reported. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score on the germline testing knowledge scale | Proportion of participants with correct responses on where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 16. Mean score and 95% CI of the total knowledge scale will be reported. | 6 months | 
| Proportion of participants with correct responses on germline testing knowledge scale | The germline testing knowledge scale is a 16 item survey where participants response with an agree or disagree to each item addressing information they have received regarding germline testing. The proportion of participants who correctly responded to each knowledge item and 95% CI for each knowledge item will be reported. | 6 months | 
| Mean score on the somatic testing knowledge scale | The somatic testing knowledge scale is a 17-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item receive a score of 1 for a total score range of 0 - 17. Mean score and 95% CI of the total knowledge scale will be reported. | 6 months | 
| Proportion of participants with correct responses on the somatic testing knowledge scale | The somatic testing knowledge scale is a 16-item survey where participants response with an True, false, or don't know to each item addressing information they have received regarding personalized cancer therapy and molecular testing (target therapy). The proportion of participants who correctly responded to each knowledge item will be reported with 95%confidence intervals. | 6 months | 
| Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE) | The collaboRATE scale is a 3 item scale with responses ranging from 0 -10 for each item which ask the participant to think about the appointment they just had. These responses will be scored using the Top Score approach which excludes cases where a response to one or more of the collaboRATE questions is missing. Each encounter is coded as either '1', if the response to all three collaboRATE items was 9, or '0' if the response to any of the three collaboRATE items was less than 9. The percentage of all encounters that were coded as '1' is the collaboRATE Score. Higher scores represent more shared decision making. This number also corresponds to the proportion of patients for whom there was 'gold standard' shared decision making. Percentage and 95% CI will be calculated. | 6 months | 
| Mean Brief Decision Support Analysis Tool (DSAT-10) scores | The Brief Decision Support Analysis Tool (DSAT-10) will be used to evaluate treating physicians' and practitioners' use of decision support and communication skills for recordings (Guimond, et al. Patient Education Counsel 2003). Encounters are reviewed and scored on 5 factors such as Decision making status, Knowledge of, Values/Preference associated with, Others' involvement with the decision, and Next Steps and given a score ranging from 1-10, with a higher score indicating a greater quality of decisional support.The DSAT-10 will be applied to calculate a mean and 95% CI of the total score (0-10) and of the 5 factors. | 6 months | 
| Proportion of providers who responded to yes for pre-test germline testing items | In addition,to the regular germline testing questionnaire, the following provider communication items will be scored as Yes or No, based on 1.2022 National Comprehensive Cancer Network (NCCN) guidelines for pre-test germline testing: Prepare patient for possible outcomes of testing, including positive, negative, and variant of uncertain significance (VUS), Discuss possible management options if a mutation is identified, Advise about possible inherited cancer risk to relatives. Discuss cost of testing, Provide overview of current legislation regarding genetic, discrimination, Provide overview of current legislation regarding privacy of genetic, information, Discuss plan for results disclosure. Proportion of providers who responded yes to each item will be reported. | 6 months | 
| Proportion of providers who responded to yes for pre-test tumor testing item | In addition,to the regular germline testing questionnaire, the following provider communication item will be scored as Yes or No, based on 1.2022 NCCN guidelines for pre-test tumor testing: Prepare patient for possible outcomes of testing. Proportion of providers who responded yes will be reported. | 6 months | 
| Proportion of participants who received the precision oncology intervention or testing | The proportion of participants who received the precision oncology intervention or testing discussed during appointment as well as the type of intervention (germline, somatic, or targeted therapy) will be reported. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Informed Decision-Making, Precision Oncology, Military Veterans, Germline Testing, Somatic Testing, Targeted Therapy, Genetic Testing