Prostate CancerNCT05958082
Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer
A study testing Educational video in people with Prostate Cancer, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Dec 2026
- 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
- Men, age greater than or equal to 18 years of age.
- Men who racially identify as black or multiracial including black
- Diagnosis of prostate cancer of any histology.
- Must meet NCCN guidelines for germline testing
- Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:
- a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
- ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer
- Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.
Who cannot join
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018.
In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.
Read the detailed description
This is a prospective, single-arm, quality improvement initiative for the use of a standardized educational intervention on germline testing in black patients with prostate cancer to improve the rates of germline genetic testing among those recommended for testing. Patients who consent to the study will undergo a one-on-one in-person education session regarding the rationale and the benefits/risks of germline testing.
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. At the start of the session, the patient will be given a short questionnaire to assess their understanding about germline and genetic testing, along with a Family History questionnaire.
Following the educational intervention, the patient will be asked to complete a short patient education and satisfaction questionnaire.
If a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay. Upon a patient deciding to pursue testing, testing will consist of a prostate cancer germline panel with a commercially available blood or saliva-based assay. Upon receipt of the results, the coordinator will alert the patient's clinician, who will then share the results with the patient either in clinic or by phone. If the results show a pathogenic germline mutation, the patient will be referred to see Henry Ford Health genetics clinic for consultation with a genetics counselor.
If a patient pursues genetic testing, following receipt of results, the patient's clinicians will be asked to complete a short survey on to assess how the results of germline testing affected the patient's current and future management.
- Conditions
- Prostate Cancer
- Being tested
- Educational video
- Keywords
- 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.
Educational videoBehavioural
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Patients will be asked questions about genetic testing for prostate cancer before and after an educational intervention. Receives: Behavioral: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing rate
percentage of patients who undergo genetic testing after completing the education session
Measured: 24 months
Secondary outcomes (3)
Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire
Pre-Intervention Patient Questionnaire: The pre-intervention patient questionnaire is a brief 16-item investigator-developed knowledge and attitude scale applicable to this population. It was developed through an expert panel to determine if participants are able to recall key core components about multigene panel testing and capture attitudes about genetic testing. This survey is estimated to take 10 minutes to complete.
Measured: Day 1, before intervention
Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire
Post-Intervention Patient Questionnaire: The post-intervention patient questionnaire is a brief 24-item investigator-developed knowledge and attitude scale applicable to this population. It includes the same 14 knowledge and attitude items from the pre-intervention survey to assess impact of the educational intervention. It was developed through an expert panel to determine if participants are able to recall key core components about multi-gene panel testing and capture attitudes about genetic testing. There is also a 10-item scale to capture satisfaction with educational intervention. This survey is estimated to take 10 minutes to complete.
Measured: Day 1, after intervention
Clinician attitudes per "Post Results Clinician Questionnaire"
Post-Results Clinician Questionnaire: The post-result clinician questionnaire is a brief 6-item investigator-developed scale to assess whether the genetic testing results altered clinical practice for any given patient including change in disease monitoring, change in recommended treatment, referral to genetic counseling and other parameters. This survey is estimated to take 5 minutes to complete.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jan 2025
- Primary completion1 Aug 2026
- Study completionDec 2026 (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 Henry Ford Health SystemThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Hwang, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958082
- Sponsor's protocol ID
- 16491
- Other IDs
- HFH-23-01
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2023
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05958082
- Acronym / sponsor ID
- 16491
- Conditions
- Prostate Cancer
- Keywords
- genetic testing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 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.
This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018.
In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.
Detailed description
This is a prospective, single-arm, quality improvement initiative for the use of a standardized educational intervention on germline testing in black patients with prostate cancer to improve the rates of germline genetic testing among those recommended for testing. Patients who consent to the study will undergo a one-on-one in-person education session regarding the rationale and the benefits/risks of germline testing.
The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. At the start of the session, the patient will be given a short questionnaire to assess their understanding about germline and genetic testing, along with a Family History questionnaire.
Following the educational intervention, the patient will be asked to complete a short patient education and satisfaction questionnaire.
If a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay. Upon a patient deciding to pursue testing, testing will consist of a prostate cancer germline panel with a commercially available blood or saliva-based assay. Upon receipt of the results, the coordinator will alert the patient's clinician, who will then share the results with the patient either in clinic or by phone. If the results show a pathogenic germline mutation, the patient will be referred to see Henry Ford Health genetics clinic for consultation with a genetics counselor.
If a patient pursues genetic testing, following receipt of results, the patient's clinicians will be asked to complete a short survey on to assess how the results of germline testing affected the patient's current and future management.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: Educational videoPatients will be asked questions about genetic testing for prostate cancer before and after an educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men, age greater than or equal to 18 years of age.
- Men who racially identify as black or multiracial including black
- Diagnosis of prostate cancer of any histology.
- Must meet NCCN guidelines for germline testing
Key exclusion criteria (2 listed)
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
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 |
|---|---|---|
| Educational videoThe educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. | Behavioural | Educational intervention |
Primary outcome
Testing rate
Time frame: 24 months
percentage of patients who undergo genetic testing after completing the education session
3 secondary outcomes
Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire
Time frame: Day 1, before intervention
Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire
Time frame: Day 1, after intervention
Clinician attitudes per "Post Results Clinician Questionnaire"
Time frame: 24 months
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 18 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Prostate Cancer, run by Henry Ford Health System 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing rate (time frame: 24 months). 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 18 Sep 2026.