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

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

Study Description

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

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Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• 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
• 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:

Breast Neoplasms; Prostatic Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Prostatic Diseases