Clinical trial · Interventional
The Genetic Education for Men Trial: Web-Based Education vs. Standard Care
The Genetic Education for Men (GEM) Trial: Web-Based Genetic Education vs. Standard Care in Men From Hereditary Cancer Families
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Care | Behavioral | — | UNRESOLVED |
| Web-based Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Web-Based Counseling
- description
- Genetic information provided via an individually tailored website.
- interventionNames
- Behavioral: Web-based Counseling
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Participants are not provided with web-based education but can choose to pursue genetic counseling and testing.
- interventionNames
- Behavioral: Standard Care
Primary outcomes (1)
- measure
- Completion of BRCA1/BRCA2 Gene Testing
- timeFrame
- 6-months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male 2. Age 25 -70 3. At least one first-, or second--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
References
Publications (1)
- DERIVEDGrisham 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