Prostate CancerNCT05396872
Patient Decision-making About Precision Oncology in Veterans With Advanced Prostate Cancer
A study testing Participant Surveys and Mobile app in people with Prostate Cancer and Advanced Prostate Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Advanced Prostate Carcinoma
- What is being tested?
- Participant Surveys and Mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 3: 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 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.
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
- Participants who do not meet the inclusion criteria above.
Stage 3: Exclusion Criteria
Patient-participants:
- Prior receipt of germline testing.
- Prior participation in Stage 1 for germline testing.
Caregiver and Provider-Participants
- If they do not meet any of the inclusion criteria above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
UCSF Genitourinary Medical Oncology Recruitment, 877-827-3222, GUTrials@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate patient-participants' decisional conflict about precision oncology. (Stage I)
II. To develop a Decision Support Intervention (DSI) to improve decision-making about precision oncology. (Stage II)
III. To evaluate the percentage of invited participants who enroll. (Stage III)
SECONDARY OBJECTIVES:
- To evaluate patient-participants' precision oncology knowledge. (Stage I).
II. To evaluate patient-participants' perceived shared decision-making effort. (Stage I)
III. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage I)
IV. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology. (Stage I)
- To evaluate patient-participants' decisional needs, and to identify potential disparities about precision oncology from the perspective of the provider-participant. (Stage I)
VI. To evaluate how many patient-participants receive a precision oncology intervention or testing after having an appointment and discussion with a provider-participant. (Stage I)
VII. To describe the multi-stakeholder development process of the DSI. (Stage II)
VIII. To evaluate change in participant informed decision-making about germline testing after provision of a decision support intervention. (Stage III)
IX. To evaluate the percent of intervention agents (people who deliver the intervention) who are willing to initiate the decision support intervention. (Stage III)
- To evaluate intervention agents' (people who deliver the intervention) fidelity to the various elements of the decision support intervention. (Stage III)
XI. To evaluate patient-participant uptake of the decision support intervention. (Stage III)
XII. To measure patient-participant satisfaction with the decision support intervention. (Stage III)
XIII. To evaluate patient-participants' perceived shared decision-making effort. (Stage III)
XIV. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage III)
XV. To evaluate provider-participant assessments of both provider- and patient-directed decision support interventions. (Stage III)
XVI. To evaluate barriers, facilitators, and experiences of the patient-directed decision support intervention by conducting patient/caregiver-participant interviews. (Stage III)
XVII. To evaluate barriers, facilitators, and experiences of the provider-directed components intervention by conducting a focus group with providers. (Stage III)
XVIII. To evaluate the consent rate of patient-participants to germline testing. (Stage III)
OUTLINE:
OBSERVATIONAL STUDY (CLOSED TO ENROLLMENT)
STAGE I: San Francisco Veterans Affairs Health Care System (SFVAHCS) patients and providers participate in an audio recorded discussion on study. Patients also complete surveys and participate in interviews on study. Caregivers and providers also participate in interviews on study. Participants medical records are reviewed throughout the 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.
INTERVENTIONAL STUDY:
STAGE III: About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid genetics adviser (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 for up to 90 days post-appointment. Providers participate in focus groups and complete surveys on study and for up to 24 months.
- Conditions
- Prostate Cancer, Advanced Prostate Carcinoma
- Being tested
- Participant Surveys, Mobile app
- Keywords
- Informed Decision-Making, Precision Oncology, Military Veterans, Germline Testing, Somatic Testing, Targeted Therapy, Genetic Testing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant SurveysOther
Online surveys administered post appointment
Mobile appOther
Mobile application installed on mobile device
| Study group | Role | What they receive |
|---|---|---|
| CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers | Experimental | 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. Receives: Other: Participant Surveys; Other: Mobile app |
| Stage 3: Patients, Caregivers using developed GA platform | Experimental | 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. Receives: Other: Participant Surveys; Other: Mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
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.
Measured: 6 months
Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
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.
Measured: 6 months
Proportion of participants enrolled (Stage 3)
The proportion of invited participants who consent to the study compared to the total number of participants approached will be reported as measured by study entry.
Measured: Up to 3 years
Proportion of participants providing reason for not enrolling (Stage 3)
The proportion of invited participants who do not consent to the study will have the reason for not joining recorded and totaled.
Measured: Up to 3 years
Secondary outcomes (21)
Mean score on the germline testing knowledge scale (Stage 1)
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.
Measured: 6 months
Mean change in germline testing knowledge score (Stage 3)
The mean change in germline testing knowledge score from baseline to 7 days post appointment will be reported for participants in Stage 3. 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 correct response to each knowledge item receives a score of 1 for a total score range of 0 - 16. Mean change in score and 95% CI of the total knowledge scale will be reported.
Measured: Up to 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Mean change in score on the Decisional Conflict Scale (DCS) (Stage 3)
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 change and 95% confidence interval (CI) of the total DCS as well as the 4 subscales will be calculated between baseline and 7 days post appointment.
Measured: Up to 6 months
Proportion of research staff and providers who agree to participate (Stage 3)
Adoption will be measured by the proportion of research staff and providers who agree to participate in the patient-directed decision support intervention divided by the number of invited providers.
Measured: Up to 6 months
Proportion of research staff who completed all components of the decision support intervention (Stage 3)
The proportions of research staff who complete each component of the patient-directed decision support intervention for each eligible patient-participant:1) decision aid platform preference assessment; 2) decision aid delivery; 3) question list coaching; 4) summary and question routing; and 5) reminder message sending, measured by verbal questionnaire.
Measured: Up to 6 months
Proportion of providers who completed all components of the decision support intervention (Stage 3)
The proportions of providers who complete each component of the provider-directed decision support intervention for each patient-participant: 1) teach back; 2) review and/or solicit questions; 3) discuss benefits of germline testing; and 4) discuss risks of germline testing, measured by analyzing the consultation audio recording.
Measured: Up to 6 months
Proportion of patient-participants who completely review the decision aid (Stage 3)
The proportion of patient-participants who completely review the decision aid, measured by user analytics 7 days post-appointment will be reported.
Measured: Up to 6 months
Proportion of patient-participants who request training for audio-recording (Stage 3)
The proportion of patient-participants who request training to audio-record their appointment who then create an audio recording, measured by questionnaire 7 days post-appointment will be reported.
Measured: Up to 6 months
Proportion of patient-participants who request question list coaching (Stage 3)
The proportion of all patient-participants who request question list coaching and who then ask at least one question from the question list during their appointment, as measured by analyzing the consultation audio recording will be reported.
Measured: Up to 6 months
Proportion of participants with responses of 9-10 on the Net Promoter Score scale (Stage 3)
The Net Promoter Score is a single item measure used to gauge satisfaction, and enthusiasm for the intervention. Total response options range from 0-10, with participants who select a response of 9 or 10 to be considered 'promoters". Responses will be obtained by questionnaire, 7 days post-appointment and the proportion of participants who respond with a choice of 9 or 10 will be reported.
Measured: Up to 6 months
Proportion of patient-participants who report "somewhat" or "very helpful" on evaluation of patient-directed intervention (Stage 3)
The proportion of patient-participants who report "somewhat helpful" or "very helpful" in their evaluation of the patient-directed intervention, and each of its components, on 5-point Likert scale with responses options of "not helpful at all", "somewhat not helpful", "neither helpful nor not helpful", "somewhat helpful", and "very helpful" measured by questionnaire. 7 days post-appointment will be reported.
Measured: Up to 6 months
Proportion of provider-participants who report "somewhat agree" or "strongly agree" to any one of the components of the intervention (Stage 3)
The proportion of provider-participants who report "somewhat" or "strongly agree" with the acceptability, feasibility, compatibility, simplicity, and relative advantage of the interventions, on a 5-point Likert scale with responses options of "strongly disagree", "somewhat disagree", "neither agree or disagree", "somewhat agree", and "strongly agree" measured by questionnaire.
Measured: Up to 6 months
Proportion of patient-participants who consent to germline testing (Stage 3)
Proportion of patient-participants who consent to germline testing, by medical record review.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start12 May 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Daniel Kwon, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396872
- Sponsor's protocol ID
- 22554
- Other IDs
- NCI-2022-04352
- Status last verified
- Mar 2026
- First submitted
- 25 May 2022
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT05396872
- Acronym / sponsor ID
- 22554
- Conditions
- Prostate Cancer, Advanced Prostate Carcinoma
- Keywords
- Informed Decision-Making, Precision Oncology, Military Veterans, Germline Testing, Somatic Testing, Targeted Therapy, Genetic Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate patient-participants' decisional conflict about precision oncology. (Stage I)
II. To develop a Decision Support Intervention (DSI) to improve decision-making about precision oncology. (Stage II)
III. To evaluate the percentage of invited participants who enroll. (Stage III)
SECONDARY OBJECTIVES:
- To evaluate patient-participants' precision oncology knowledge. (Stage I).
II. To evaluate patient-participants' perceived shared decision-making effort. (Stage I)
III. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage I)
IV. To evaluate patient-participants' and caregiver-participants' decisional needs, potential solutions, and potential disparities about precision oncology. (Stage I)
- To evaluate patient-participants' decisional needs, and to identify potential disparities about precision oncology from the perspective of the provider-participant. (Stage I)
VI. To evaluate how many patient-participants receive a precision oncology intervention or testing after having an appointment and discussion with a provider-participant. (Stage I)
VII. To describe the multi-stakeholder development process of the DSI. (Stage II)
VIII. To evaluate change in participant informed decision-making about germline testing after provision of a decision support intervention. (Stage III)
IX. To evaluate the percent of intervention agents (people who deliver the intervention) who are willing to initiate the decision support intervention. (Stage III)
- To evaluate intervention agents' (people who deliver the intervention) fidelity to the various elements of the decision support intervention. (Stage III)
XI. To evaluate patient-participant uptake of the decision support intervention. (Stage III)
XII. To measure patient-participant satisfaction with the decision support intervention. (Stage III)
XIII. To evaluate patient-participants' perceived shared decision-making effort. (Stage III)
XIV. To evaluate the degree of decision support provided by provider-participants during an appointment with the patient-participant. (Stage III)
XV. To evaluate provider-participant assessments of both provider- and patient-directed decision support interventions. (Stage III)
XVI. To evaluate barriers, facilitators, and experiences of the patient-directed decision support intervention by conducting patient/caregiver-participant interviews. (Stage III)
XVII. To evaluate barriers, facilitators, and experiences of the provider-directed components intervention by conducting a focus group with providers. (Stage III)
XVIII. To evaluate the consent rate of patient-participants to germline testing. (Stage III)
OUTLINE:
OBSERVATIONAL STUDY (CLOSED TO ENROLLMENT)
STAGE I: San Francisco Veterans Affairs Health Care System (SFVAHCS) patients and providers participate in an audio recorded discussion on study. Patients also complete surveys and participate in interviews on study. Caregivers and providers also participate in interviews on study. Participants medical records are reviewed throughout the 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.
INTERVENTIONAL STUDY:
STAGE III: About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid genetics adviser (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 for up to 90 days post-appointment. Providers participate in focus groups and complete surveys on study and for up to 24 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers | Experimental | Other: Participant Surveys, Other: Mobile appPatient 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. |
| Stage 3: Patients, Caregivers using developed GA platform | Experimental | Other: Participant Surveys, Other: Mobile appAbout 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant SurveysOnline surveys administered post appointment | Other | CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers, Stage 3: Patients, Caregivers using developed GA platform |
| Mobile appMobile application installed on mobile device | Other | CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers, Stage 3: Patients, Caregivers using developed GA platform |
Primary outcome
Mean score on the Decisional Conflict Scale (DCS) (Stage 1)
Time frame: 6 months
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.
Proportion of participants with a total score of >37.5 on the DCS (Stage 1)
Time frame: 6 months
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.
Proportion of participants enrolled (Stage 3)
Time frame: Up to 3 years
The proportion of invited participants who consent to the study compared to the total number of participants approached will be reported as measured by study entry.
Proportion of participants providing reason for not enrolling (Stage 3)
Time frame: Up to 3 years
The proportion of invited participants who do not consent to the study will have the reason for not joining recorded and totaled.
21 secondary outcomes
Mean score on the germline testing knowledge scale (Stage 1)
Time frame: 6 months
Mean change in germline testing knowledge score (Stage 3)
Time frame: Up to 6 months
Proportion of participants with correct responses on germline testing knowledge scale
Time frame: 6 months
Mean score on the somatic testing knowledge scale
Time frame: 6 months
Proportion of participants with correct responses on the somatic testing knowledge scale
Time frame: 6 months
Proportion of patients for whom there was 'gold standard' shared decision making (collaboRATE)
Time frame: 6 months
Mean Brief Decision Support Analysis Tool (DSAT-10) scores
Time frame: 6 months
Proportion of providers who responded to yes for pre-test germline testing items
Time frame: 6 months
Proportion of providers who responded to yes for pre-test tumor testing item
Time frame: 6 months
Proportion of participants who received the precision oncology intervention or testing
Time frame: 6 months
Mean change in score on the Decisional Conflict Scale (DCS) (Stage 3)
Time frame: Up to 6 months
Proportion of research staff and providers who agree to participate (Stage 3)
Time frame: Up to 6 months
Proportion of research staff who completed all components of the decision support intervention (Stage 3)
Time frame: Up to 6 months
Proportion of providers who completed all components of the decision support intervention (Stage 3)
Time frame: Up to 6 months
Proportion of patient-participants who completely review the decision aid (Stage 3)
Time frame: Up to 6 months
Proportion of patient-participants who request training for audio-recording (Stage 3)
Time frame: Up to 6 months
Proportion of patient-participants who request question list coaching (Stage 3)
Time frame: Up to 6 months
Proportion of participants with responses of 9-10 on the Net Promoter Score scale (Stage 3)
Time frame: Up to 6 months
Proportion of patient-participants who report "somewhat" or "very helpful" on evaluation of patient-directed intervention (Stage 3)
Time frame: Up to 6 months
Proportion of provider-participants who report "somewhat agree" or "strongly agree" to any one of the components of the intervention (Stage 3)
Time frame: Up to 6 months
Proportion of patient-participants who consent to germline testing (Stage 3)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Kwon, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant Surveys and Mobile app in people with Prostate Cancer and Advanced Prostate Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCSF Genitourinary Medical Oncology Recruitment (877-827-3222, GUTrials@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score on the Decisional Conflict Scale (DCS) (Stage 1) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.