Prostate Cancer
Conditions
Keywords
Prostate Cancer, Genetics
Brief summary
This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.
Detailed description
Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling. Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care. Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.
Interventions
OTHERTraditional pre-test genetic counseling
Participant meets with a genetic counselor at the Center for Cancer Genetics and Prevention and traditional pre-test cancer genetic counseling is provided
OTHERPre-test video education
The video is designed to mirror the educational components of a traditional genetic counseling visit
Sponsors
University of Texas Southwestern Medical Center
Barbara Ann Karmanos Cancer Institute
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant) * Localized prostate cancer with Gleason score ≥8 * Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months * Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart * Prostate cancer diagnosed at age ≤ 55 years * Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer. * Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)
Exclusion criteria
* Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place. * Localized prostate cancer previously treated and in remission for \> 2 years unless family history potentially indicates a germline mutation. * Active hematologic malignancy (e.g. CLL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of germline mutations in males with prostate cancer | 2 years | The proportion of participants who test positive for pathogenic or likely pathogenic variants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary or other primary (non-prostate) malignancies | 2 years | Assessed by chart review. Participants with positive genetic test results will fill out the Positive Test Results Survey to report any additional cancer diagnoses. |
| Genetic testing satisfaction score | at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure | A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are disagree strongly, disagree, neither agree or disagree, agree, and agree strongly. At the time of 1 month post-result disclosure, an additional set of 5 questions will be added. Four of these five questions will be evaluated using the previously described parameters. The remaining question will be answered by the response options: yes, no, or I did not get the packet. Survey responses will be re-coded on a numerical scale consistent with the standard Likert scale. |
| Multidimensional Impact of Cancer Risk Assessment score and subscales | 1 and 4 months post-result disclosure | MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this. |
| Genetic testing uptake | 2 years | The proportion of participants who consent to genetic testing in the pre-test video education arm |
| Family communication for those who tested positive for a genetic mutation | 1 and 4 months post-result disclosure | For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature. |
| Intent to disclose genetic test results | pre-result disclosure | Three items will assess participants' intentions to disclose genetic testing results. |
| Knowledge of multigene panel testing score | 4 months post-result disclosure | A 24 item investigator-developed knowledge scale applicable to this population was developed through an expert panel and in-depth patient cognitive interviews to determine if participants are able to recall key core components about multi-gene panel testing. Each item provides three choice answers: agree, disagree, or I don't know. Knowledge will be scored on the number of correct responses where higher correct responses represents more knowledge of multigene panel testing. |
Countries
United States
Outcome results
None listed