Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)

Prostate Cancer Clinical Trial

— ProGen  

Official title:

Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328091
• Other study ID #: 17-409
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: February 13, 2020

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• Pre-test video education
The video is designed to mirror the educational components of a traditional genetic counseling visit

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Barbara Ann Karmanos Cancer Institute, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of germline mutations in males with prostate cancer	The proportion of participants who test positive for pathogenic or likely pathogenic variants	2 years
Secondary	Genetic testing uptake	The proportion of participants who consent to genetic testing in the pre-test video education arm	2 years
Secondary	Secondary or other primary (non-prostate) malignancies	Assessed by chart review. Participants with positive genetic test results will fill out the "Positive Test Results" Survey to report any additional cancer diagnoses.	2 years
Secondary	Genetic testing satisfaction score	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.	at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure
Secondary	Multidimensional Impact of Cancer Risk Assessment score and subscales	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.	1 and 4 months post-result disclosure
Secondary	Knowledge of multigene panel testing score	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.	4 months post-result disclosure
Secondary	Family communication for those who tested positive for a genetic mutation	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.	1 and 4 months post-result disclosure
Secondary	Intent to disclose genetic test results	Three items will assess participants' intentions to disclose genetic testing results.	pre-result disclosure