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

NCT02957981 | Completed

• 1 other identifier: 2016-1162
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma; Breast Neoplasm; Pancreatic Cancer; BRCA1 Mutation; BRCA2 Mutation

Keywords

BRCA1; BRCA2; Men; Hereditary Cancer; Prostate Cancer; Male Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Completion of BRCA1/BRCA2 Gene Testing

  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.

  6-months

Secondary Outcomes (3)

• Completion of Genetic Counseling

  6-months

• Decision Satisfaction

  6-Months

• Decision Conflict

  6-Months

Other Outcomes (2)

• Cancer Distress

  6-Months

• Genetic Testing Distress

  6-Months

Study Arms (2)

Web-Based Counseling

EXPERIMENTAL

Genetic information provided via an individually tailored website.

Behavioral: Web-based Counseling

Standard Care

ACTIVE COMPARATOR

Participants are not provided with web-based education but can choose to pursue genetic counseling and testing.

Behavioral: Standard Care

Interventions

Web-based Counseling BEHAVIORAL

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.

Web-Based Counseling

Standard Care BEHAVIORAL

Standard care includes access to resource list for men from hereditary cancer families plus access to standard clinical genetic counseling

Standard Care

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age 25 -70
• At least one first-, or second--degree relative who has been found to carry a BRCA1 or BRCA2 mutation.

You may not qualify if:

• Personal diagnosis of any cancer, other than non-melanoma skin cancer
• Prior genetic counseling or testing for hereditary breast/ovarian cancer
• 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
• 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
• Have one one or more children who are BRCA1 or BRCA2 positive
• Cannot participate in or understand English
• Cannot provide meaningful informed consent

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• Grisham C, Peshkin BN, Sorgen L, Isaacs C, Ladd MK, Jacobs A, Binion S, Tynan M, Kuchinsky E, Friedman S, Taylor KL, Graves K, O'Neill S, Kim D, Schwartz MD. Streamlined Genetic Education and Cascade Testing in Men from Hereditary Breast Ovarian Cancer Families: A Randomized Trial. Public Health Genomics. 2024;27(1):100-109. doi: 10.1159/000540466. Epub 2024 Aug 22.

  PMID: 39173603 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Multiple Endocrine Neoplasia Type 1; Breast Neoplasms, Male

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Multiple Endocrine Neoplasia; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology, Associate Director for Population Science

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 8, 2016
• Study Start: October 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)