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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03328091
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Huma Rana, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Traditional pre-test genetic counseling Other: Pre-test video education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
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
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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
  • 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
Other: Pre-test video education
The video is designed to mirror the educational components of a traditional genetic counseling visit




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Genetic testing uptake [ Time Frame: 2 years ]
    The proportion of participants who consent to genetic testing in the pre-test video education arm

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Intent to disclose genetic test results [ Time Frame: pre-result disclosure ]
    Three items will assess participants' intentions to disclose genetic testing results.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • 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.
  • Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.

Information from the National Library of Medicine

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


Contacts
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Contact: Donna Rachel Vatnick 617-632-2077 Donna_Vatnick@DFCI.HARVARD.EDU

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Donna Rachel Vatnick    617-632-2077    Donna_Vatnick@DFCI.HARVARD.EDU   
Principal Investigator: Huma Q Rana, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Huma Q Rana, MD Dana-Farber Cancer Institute

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Responsible Party: Huma Rana, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03328091     History of Changes
Other Study ID Numbers: 17-409
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huma Rana, Dana-Farber Cancer Institute:
Prostate Cancer
Genetics

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases