Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen) (ProGen)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03328091|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : January 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Traditional pre-test genetic counseling Other: Pre-test video education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||662 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)|
|Actual Study Start Date :||November 21, 2017|
|Actual Primary Completion Date :||February 13, 2020|
|Estimated Study Completion Date :||November 30, 2023|
Active Comparator: Traditional pre-test genetic counseling
Other: Traditional 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
Experimental: Pre-test video education
Other: Pre-test video education
The video is designed to mirror the educational components of a traditional genetic counseling visit
- Prevalence of germline mutations in males with prostate cancer [ Time Frame: 2 years ]The proportion of participants who test positive for pathogenic or likely pathogenic variants
- Genetic testing uptake [ Time Frame: 2 years ]The proportion of participants who consent to genetic testing in the pre-test video education arm
- Secondary or other primary (non-prostate) malignancies [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Knowledge of multigene panel testing score [ Time Frame: 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.
- Family communication for those who tested positive for a genetic mutation [ Time Frame: 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 [ Time Frame: pre-result disclosure ]Three items will assess participants' intentions to disclose genetic testing results.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328091
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Huma Q Rana, MD||Dana-Farber Cancer Institute|
|Responsible Party:||Huma Rana, MD, Principal Investigator, Dana-Farber Cancer Institute|
|Other Study ID Numbers:||
|First Posted:||November 1, 2017 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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