Prostate Cancer
Conditions
Keywords
Prostate cancer, Germline testing, Education, Video
Brief summary
A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
Detailed description
This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.
Interventions
BEHAVIORALEducational intervention.
Educational intervention with trained educator on overview, rationale, implications, and risks and benefits of germline testing in prostate cancer.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men, age greater than or equal to 18 years of age. 2. Diagnosis of prostate cancer of any histology. 3. Must meet NCCN guidelines for germline testing
Exclusion criteria
1. Have had prior germline testing. 2. Have somatic genetic testing that is positive for a possible germline variant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention. | Within 1 year | Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Baseline Knowledge of Germline Testing | Baseline | Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge |
| Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing | Within 18 months | Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge |
| Number of Participants With Pathogenic Germline Mutations | within 18 months | Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance. |
| Patient Knowledge of Germline Testing After the Educational Intervention. | within 18 months | Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRana McKay, MD
UCSD
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education Intervention Group In-clinic educational session on germline testing in prostate cancer with a trained educator including video intervention. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Education Intervention Group |
|---|---|
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Family history Family history of cancer | 35 Participants |
| Family history No family history of cancer | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.
Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
Time frame: Within 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Group | Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention. | 41 Participants |
Secondary
Number of Participants With Pathogenic Germline Mutations
Assessment via tabulation of all germline pathogenic, likely pathogenic mutations and and variants of uncertain significance.
Time frame: within 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Group | Number of Participants With Pathogenic Germline Mutations | 5 Participants |
Secondary
Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing
Assessment via post intervention questionnaire. Survey Title: Patient Post-Education Patient Survey Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge
Time frame: Within 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Intervention Group | Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing | 9.2 Units on a scale |
Secondary
Patient Baseline Knowledge of Germline Testing
Assessment via baseline knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Intervention Group | Patient Baseline Knowledge of Germline Testing | 9.1 Units on a scale |
Secondary
Patient Knowledge of Germline Testing After the Educational Intervention.
Assessment via post intervention knowledge questionnaire. Survey Title: Patient Survey on Germline Testing in Prostate Cancer Minimum Values: 0 (No knowledge) Maximum Values: 11 (Highest knowledge) Higher score = higher knowledge
Time frame: within 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Intervention Group | Patient Knowledge of Germline Testing After the Educational Intervention. | 9.2 units on a scale |