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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

662 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2020-02-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Traditional pre-test genetic counseling

* In-person consultation with licensed genetic counselor at the Center for Cancer Genetics and Prevention before genetic testing
* Participant is given a pamphlet introducing prostate cancer genes, genetic testing
* Participant is sent electronic family history tool
* Participant is given the "Genetic Testing Information for Decision Making" packet. After the genetic counseling session, patient is asked if they would like to proceed with genetic testing.

Group Type ACTIVE_COMPARATOR

Traditional pre-test genetic counseling

Intervention Type OTHER

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

* Participant is given a pamphlet that describes the basics of prostate cancer genes, genetic testing
* Participant is sent electronic family history tool
* Participant is approached in clinic by research staff at a pre-planned time
* The patient is given the "Genetic Testing Information for Decision Making" packet
* The pre-test video education is a short video. Information will be provided about the basics of genetics and mutations, the potential benefits, risks, and limitations of genetic testing, and the possible results the participant may receive

Group Type EXPERIMENTAL

Pre-test video education

Intervention Type OTHER

The video is designed to mirror the educational components of a traditional genetic counseling visit

Interventions

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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

Intervention Type OTHER

Pre-test video education

The video is designed to mirror the educational components of a traditional genetic counseling visit

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No