N/A
N=668
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project
Breast Cancer · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03326713 ↗Enrolled (actual)
668
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months — 5; 6; 32 Participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telephone Counseling & Navigation (TCN) (Behavioral); Mailed Targeted Print (TP) (Behavioral); Usual Care (UC) (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months |
5; 6; 32 | <.0001 sig |
| SECONDARY Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months |
23; 21; 45 | — |
| SECONDARY Decisional Conflict for CGRA: SURE Scale |
2.44; 2.55; 3.33 | — |
| SECONDARY Cancer Genetic Risk Assessment Intention |
2.69; 2.78; 3.44 | — |
Summary
GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP) or 2) a tailored telephone-based counseling and navigation intervention (TCN). Post-award, the target sample size was revised to (n=642) with NIH permission.
Eligibility Criteria
Inclusion Criteria
Breast Cancer
- Hispanic or non-Hispanic
- Female
- 21 years of age or older
- English-speaking
- Breast cancer history
- breast cancer at the age of 50 or younger OR
- triple-negative breast cancer OR
- two or more primary breast cancers
Ovarian Cancer
- Hispanic or non-Hispanic
- Female
- 21 years of age or older
- English-speaking
- History of ovarian, fallopian, or peritoneal cancer diagnosed at any age
Exclusion Criteria
Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
Data sourced from ClinicalTrials.gov (NCT03326713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.