Clinical trial · Interventional
Scalable Communication Modalities for Returning Genetic Research Results
Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women
- 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)
Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Breast and Ovarian Cancer | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic counselor follow-up | Behavioral | — | UNRESOLVED |
| Online modality | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional modality
- description
- Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.
- type
- EXPERIMENTAL
- label
- Online modality
- description
- Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.
- interventionNames
- Behavioral: Online modality
- Behavioral: Genetic counselor follow-up
Primary outcomes (15)
- measure
- Number of participant that decide to learn genetic results at 6 weeks
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: -Women in the BWHS previously included in the targeted breast cancer sequencing project Exclusion Criteria: * Women with known cognitive impairments * Women with variant of uncertain significance (VUS) results from the sequencing study
References
Publications (1)
- DERIVEDWang C, Bertrand KA, Trevino-Talbot M, Flynn M, Ruderman M, Cabral HJ, Bowen DJ, Hughes-Halbert C, Palmer JR. Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women. Contemp Clin Trials. 2023 Sep;132:107309. doi: 10.1016/j.cct.2023.107309. Epub 2023 Jul 27. PMID 37516165