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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional pre-test genetic counseling
Pre-test video education
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Dana-Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional pre-test genetic counseling

Pre-test video education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Prevalence of germline mutations in males with prostate cancer
The proportion of participants who test positive for pathogenic or likely pathogenic variants

Secondary Outcome Measures

Genetic testing uptake
The proportion of participants who consent to genetic testing in the pre-test video education arm
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.
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.
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.
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.
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.
Intent to disclose genetic test results
Three items will assess participants' intentions to disclose genetic testing results.

Full Information

First Posted
October 25, 2017
Last Updated
January 25, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
University of Texas Southwestern Medical Center, Barbara Ann Karmanos Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03328091
Brief Title
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Acronym
ProGen
Official Title
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
University of Texas Southwestern Medical Center, Barbara Ann Karmanos Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Genetics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
662 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Q Rana, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36103646
Citation
Berchuck JE, Boiarsky D, Silver R, Sunkara R, McClure HM, Tsai HK, Siegmund S, Tewari AK, Nowak JA, Lindeman NI, Rana HQ, Choudhury AD, Pomerantz MM, Freedman ML, Van Allen EM, Taplin ME. Addition of Germline Testing to Tumor-Only Sequencing Improves Detection of Pathogenic Germline Variants in Men With Advanced Prostate Cancer. JCO Precis Oncol. 2022 Aug;6:e2200329. doi: 10.1200/PO.22.00329.
Results Reference
derived

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

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