Prostate CancerNCT06171139
Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
A study testing Counseling Tool and Questionnaires in people with Prostate Cancer and Prostate Cancer Metastatic, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- Counseling Tool and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 31 Aug 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written information sheet and willing to verbally consent.
Show all 18Show fewer
- Fluent in English (reading, writing, and speaking)
- Stage 2:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Fluent in English (reading, writing, and speaking).
- Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:
- Somatic DNA testing of already-collected tissue.
- Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
- Blood-based DNA testing to evaluate for circulating tumor DNA.
- Able to understand a written informed consent document and willing to sign it.
Who cannot join
- Contraindication to any study-related procedure or assessment in either stage.
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
University of California
San Francisco, California, 94143
Daniel Avins, Daniel.Avins@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.
Read the detailed description
PRIMARY OBJECTIVES:
Stage 1: To evaluate education quality of the intervention in Black or African American men with prostate cancer.
Stage 2: To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer
SECONDARY OBJECTIVES:
Stage 1:
- To evaluate completeness of the intervention content.
- To identify barriers and facilitators for using the intervention.
Stage 2:
- To evaluate the acceptability of the intervention among Black or African American men with prostate cancer.
- To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate patient perspectives on the intervention.
- To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool.
OUTLINE:
This is a two-stage study. In Stage 1, Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT, or who have decided to undergo TGT, or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days. The investigators will then refine the tool to be piloted in Stage 2.
Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Counseling Tool, Questionnaires
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling ToolOther
Non-therapeutic educational intervention
QuestionnairesOther
Also called Surveys
Participants will complete questionnaires online, via mail, by telephone, or in person per participant preference.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Tool Development | Experimental | Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed. Receives: Other: Counseling Tool; Other: Questionnaires |
| Stage 1: Tool Implementation (Pilot Study) | Experimental | Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview. Receives: Other: Counseling Tool; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of participant responses (Stage 1)
Participant-reported perspectives of intervention in a semi-structured interview will be collected during Stage 1 and reviewed and will be explored using thematic analysis. A codebook will be created using the PEMAT (for the primary objective) described in the interview guide. This framework provides a systematic approach for identifying behavior change models evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behavior. This will produce evidence-based behavior change techniques most likely to be effective. Emergent codes and themes will be added throughout thematic analysis. Two coders will code each interview (one primary and one secondary coder). Discrepancies will be negotiated to consensus.
Measured: 1 day
Proportion of enrolled participants (Stage 2)
The proportion of participants who enrolled in the study after being approached by their healthcare team will be reported.
Measured: 1 day
Proportion of enrolled participants who review all educational materials (Stage 2)
The proportion of all enrolled participants who utilized and reviewed all of the educational materials in the tool will be reported.
Measured: Up to 60 days
Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)
Scores on the FIM will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.
Measured: Up to 60 days
Secondary outcomes (8)
Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)
Scores on the AIM items will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.
Measured: Up to 60 days
Mean score of investigator-developed, measure of acceptability items (Stage 2)
Scores on the 5-item investigator-developed, measure of acceptability will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported. However, responses will not be averaged to across items; each item will be analyzed independently.
Measured: Up to 60 days
Mean score of cancer genomic testing knowledge (Stage 2)
Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al.+ select questions from a survey from Rogith, et al.will be utilized to measure the level of cancer genomic testing knowledge. "Don't know" will be scored as incorrect. The proportion of correct responses will be calculated to generate a total score between 0-100, with a higher score indicating greater knowledge. No items will be weighted. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.
Measured: Up to 60 days
Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)
Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al. including select questions from a survey from Rogith, et al. and is designed to measure the level of cancer genomic testing knowledge. Responses of "Don't know" will be scored as incorrect. Each of the item scores will be reported as a proportion of the participants who answered each item correctly. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.
Measured: Up to 60 days
Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
Attitude and expectations measure for tumor genetic testing is a 17-item measure adapted from a validated survey from Blanchette, et al. including one open-ended investigator-created item. Items on the attitude scoring scale range from "Yes" = 1 and "No" or "Unsure" = 0.
Measured: Up to 60 days
Proportion of participants who answer "Strongly Agree" or "Agree" to the expectation item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
The attitude and expectations for tumor genetic testing is a measure adapted from a validated survey from Blanchette, et al. and includes one open-ended investigator-created item. The expectations scoring (item 3): "Strongly Agree" or "Agree" = 1 and all other responses = 0
Measured: Up to 60 days
Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2)
Participant-reported perspectives of intervention in a semi-structured interview will be collected during Stage 1 and reviewed and will be explored using thematic analysis. A codebook will be created using the COM-B ((capability (C), opportunity (O), and motivation (M) / BCW domains (for the secondary objectives) described in the interview guide. This framework provides a systematic approach for identifying behavior change models evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behavior. This will produce evidence-based behavior change techniques most likely to be effective. Emergent codes and themes will be added throughout thematic analysis. Two coders will code each interview (one primary and one secondary coder). Discrepancies will be negotiated to consensus.
Measured: Up to 60 days
Proportion of participants who have received the tumor genetic pre-test counseling tool who undergo TGT by chart review (Stage 2)
A medical record review of TGT completion date will be conducted. If TGT was not completed, the study staff will review and record reasons for non-completion, and date of last follow-up.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Dec 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel Kwon, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171139
- Sponsor's protocol ID
- 23553
- Other IDs
- NCI-2023-10339
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2023
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06171139
- Acronym / sponsor ID
- 23553
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Dec 2023 (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.
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.
Detailed description
PRIMARY OBJECTIVES:
Stage 1: To evaluate education quality of the intervention in Black or African American men with prostate cancer.
Stage 2: To evaluate feasibility of the TGT intervention among Black or African American men with prostate cancer
SECONDARY OBJECTIVES:
Stage 1:
- To evaluate completeness of the intervention content.
- To identify barriers and facilitators for using the intervention.
Stage 2:
- To evaluate the acceptability of the intervention among Black or African American men with prostate cancer.
- To evaluate change in participant knowledge about tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate change in patient attitudes toward tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate change in participant expectations of tumor genetic testing among Black or African American men with prostate cancer.
- To evaluate patient perspectives on the intervention.
- To evaluate the rate of TGT among Black or African American men with prostate cancer who have received the tumor genetic pre-test counseling tool.
OUTLINE:
This is a two-stage study. In Stage 1, Adult Black or African American men with metastatic prostate cancer who have not made a decision about TGT, or who have decided to undergo TGT, or patients who have decline TGT about tumor genetic testing will participate in development by answering questionnaires and utilizing the pilot application for up to 60 days. The investigators will then refine the tool to be piloted in Stage 2.
Stage 2: A pilot study of participants who are planning to have a discussion about undergoing tumor genetic testing with their oncology provider will be invited to join and utilize the tool, and answer questionnaires about the tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Tool Development | Experimental | Other: Counseling Tool, Other: QuestionnairesParticipants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed. |
| Stage 1: Tool Implementation (Pilot Study) | Experimental | Other: Counseling Tool, Other: QuestionnairesParticipants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written information sheet and willing to verbally consent.
Key exclusion criteria (1 listed)
- Contraindication to any study-related procedure or assessment in either stage.
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 |
|---|---|---|
| Counseling ToolNon-therapeutic educational intervention | Other | Stage 1: Tool Development, Stage 1: Tool Implementation (Pilot Study) |
| QuestionnairesAlso: SurveysParticipants will complete questionnaires online, via mail, by telephone, or in person per participant preference. | Other | Stage 1: Tool Development, Stage 1: Tool Implementation (Pilot Study) |
Primary outcome
Frequency of participant responses (Stage 1)
Time frame: 1 day
Participant-reported perspectives of intervention in a semi-structured interview will be collected during Stage 1 and reviewed and will be explored using thematic analysis. A codebook will be created using the PEMAT (for the primary objective) described in the interview guide. This framework provides a systematic approach for identifying behavior change models evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behavior. This will produce evidence-based behavior change techniques most likely to be effective. Emergent codes and themes will be added throughout thematic analysis. Two coders will code each interview (one primary and one secondary coder). Discrepancies will be negotiated to consensus.
Proportion of enrolled participants (Stage 2)
Time frame: 1 day
The proportion of participants who enrolled in the study after being approached by their healthcare team will be reported.
Proportion of enrolled participants who review all educational materials (Stage 2)
Time frame: Up to 60 days
The proportion of all enrolled participants who utilized and reviewed all of the educational materials in the tool will be reported.
Mean score of Feasibility of Intervention Measure (FIM) (Stage 2)
Time frame: Up to 60 days
Scores on the FIM will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. A higher mean score indicates greater feasibility. The mean score and standard deviation will be reported.
8 secondary outcomes
Mean score of Acceptability of Intervention Measure (AIM) (Stage 2)
Time frame: Up to 60 days
Mean score of investigator-developed, measure of acceptability items (Stage 2)
Time frame: Up to 60 days
Mean score of cancer genomic testing knowledge (Stage 2)
Time frame: Up to 60 days
Proportion of participants who select correct response in each genomic testing knowledge instrument item (Stage 2)
Time frame: Up to 60 days
Proportion of participants who answer "Yes" to each attitude item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
Time frame: Up to 60 days
Proportion of participants who answer "Strongly Agree" or "Agree" to the expectation item in the Attitude and expectations for tumor genetic testing survey (Stage 2)
Time frame: Up to 60 days
Participant-reported perspectives of intervention in a semi-structured interview. (Stage 2)
Time frame: Up to 60 days
Proportion of participants who have received the tumor genetic pre-test counseling tool who undergo TGT by chart review (Stage 2)
Time frame: Up to 90 days
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 16 Apr 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 Counseling Tool and Questionnaires in people with Prostate Cancer and Prostate Cancer Metastatic, 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?
The sponsor lists 18 inclusion and 1 exclusion criteria. 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 16 Apr 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 Daniel Avins (877-827-3222, Daniel.Avins@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of participant responses (Stage 1) (time frame: 1 day). 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 16 Apr 2026.