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The Genetic Education for Men Trial: Web-Based Education vs. Standard Care (GEM)

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ClinicalTrials.gov Identifier: NCT02957981
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Marc D Schwartz, Georgetown University

Brief Summary:
The primary goal of this research is to develop and test a web-based genetic education/counseling intervention. This intervention is designed to educate men from hereditary cancer families about the personal relevance of genetic testing in order to help them make decisions about whether to pursue genetic testing. The investigators will test this intervention against standard care for men from hereditary cancer families. The web-based educational intervention includes all of the information typically covered during genetic counseling. As a result, after completing the education intervention participants can proceed directly to genetic testing if they choose. The investigators will conduct a survey prior to randomization and then follow-up surveys at 1-month and 6-months post-randomization. The primary outcome will be uptake of genetic testing. Secondary outcomes will be completion of genetic counseling and decision satisfaction.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Breast Neoplasm Pancreatic Cancer BRCA1 Mutation BRCA2 Mutation Behavioral: Web-based Counseling Behavioral: Standard Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Genetic Education for Men (GEM) Trial: Web-Based Genetic Education vs. Standard Care in Men From Hereditary Cancer Families
Study Start Date : October 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Web-Based Counseling
Genetic information provided via an individually tailored website.
Behavioral: Web-based Counseling
The web-based genetic counseling and education intervention will include standard information typically provided in individual genetic counseling. the intervention will be individually tailored based upon key clinical and demographic characteristics of the participant.

Active Comparator: Standard Care
Participants are not provided with web-based education but can choose to pursue genetic counseling and testing.
Behavioral: Standard Care
Standard care includes access to resource list for men from hereditary cancer families plus access to standard clinical genetic counseling




Primary Outcome Measures :
  1. Completion of BRCA1/BRCA2 Gene Testing [ Time Frame: 6-months ]
    The number of participants in each arm who choose to be tested for the BRCA1 or BRCA2 mutation that has previously been identified in their family.


Secondary Outcome Measures :
  1. Completion of Genetic Counseling [ Time Frame: 6-months ]
    The number of men in each arm who choose to obtain genetic counseling

  2. Decision Satisfaction [ Time Frame: 6-Months ]
    Scores on the satisfaction with decision scale at 6-months post-randomization

  3. Decision Conflict [ Time Frame: 6-Months ]
    Scores on the decision conflict scale at 6-months post-randomization


Other Outcome Measures:
  1. Cancer Distress [ Time Frame: 6-Months ]
    Impact of Events Scale

  2. Genetic Testing Distress [ Time Frame: 6-Months ]
    Multidimensional Impact of Cancer Risk Assessment Scale



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male
  2. Age 30 -70
  3. At least one first-, second- or third-degree relative who has been found to carry a BRCA1 or BRCA2 mutation.

Exclusion Criteria:

  1. Personal diagnosis of any cancer, other than non-melanoma skin cancer
  2. Prior genetic counseling or testing for hereditary breast/ovarian cancer
  3. Family history suggestive of a hereditary cancer syndrome not attributable to the BRCA1 or BRCA2 mutation in their family, based on pedigree review by the study team
  4. An uncertain risk of carrying the familial BRCA1 or BRCA2 mutation (e.g., because it is not clear on what side of the family the mutation is segregating), based on pedigree review by the study team
  5. Have one one or more children who are BRCA1 or BRCA2 positive
  6. Cannot participate in or understand English
  7. Cannot provide meaningful informed consent

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): NCT02957981


Locations
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United States, District of Columbia
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Marc D Schwartz, PhD    202-687-0185    schwartm@georgetown.edu   
Principal Investigator: Marc D Schwartz, PhD         
Sub-Investigator: Beth N Peshkin, MS         
Sub-Investigator: Kathryn L Taylor, PhD         
Sub-Investigator: Claudine Isaacs, MD         
Sub-Investigator: Kristi Graves, PhD         
Sponsors and Collaborators
Georgetown University

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Responsible Party: Marc D Schwartz, Professor of Oncology, Associate Director for Population Science, Georgetown University
ClinicalTrials.gov Identifier: NCT02957981     History of Changes
Other Study ID Numbers: 2016-1162
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared with other researchers.
Keywords provided by Marc D Schwartz, Georgetown University:
BRCA1
BRCA2
Men
Hereditary Cancer
Prostate Cancer
Male Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases