Results for the Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project, investigating interventions to increase cancer genetic risk assessment (CGRA) uptake in individuals with breast and ovarian cancer, were posted on ClinicalTrials.gov on 2025-05-28. The tailored counseling and navigation (TCN) intervention significantly increased medically verified CGRA uptake at 6 months, with an odds ratio of 7.4 (95% CI: 2.8, 19.4) compared to usual care.
Background
Breast cancer and ovarian cancer are conditions for which genetic predisposition plays a significant role in a subset of cases. Identifying individuals at higher genetic risk through cancer genetic risk assessment (CGRA) can inform prevention strategies, early detection, and treatment decisions for patients and their families. Despite its importance, uptake of CGRA can be low due to various barriers, highlighting the need for effective communication and navigation interventions.
Trial design
The GRACE Project was a randomized, 3-arm trial designed to determine the comparative effectiveness of two remote cancer communication interventions. The trial enrolled 668 participants, with a revised target sample size of 642. The study focused on individuals with Breast Cancer and Ovarian Cancer. The three arms included: 1) Usual Care (UC), 2) a targeted generic print (TP) intervention, and 3) a tailored telephone-based counseling and navigation (TCN) intervention. The primary focus of the trial was to assess the uptake of medically verified cancer genetic risk assessment.
Key results
The trial reported on several key measurements related to cancer genetic risk assessment uptake and related psychological factors:
- Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months:
- 5 participants in the Usual Care (UC) group.
- 6 participants in the Tailored Print (TP) group.
- 32 participants in the Tailored Counseling and Navigation (TCN) group.
- Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months:
- 23 participants in the Usual Care (UC) group.
- 21 participants in the Tailored Print (TP) group.
- 45 participants in the Tailored Counseling & Navigation (TCN) group.
- Decisional Conflict for CGRA: SURE Scale (score on a scale):
- Usual Care (UC): mean 2.44 (Standard Deviation 2.11).
- Tailored Print (TP): mean 2.55 (Standard Deviation 1.79).
- Tailored Counseling & Navigation (TCN): mean 3.33 (Standard Deviation 1.16).
- Cancer Genetic Risk Assessment Intention (units on a scale):
- Usual Care (UC): mean 2.69 (Standard Deviation 1.27).
- Tailored Print (TP): mean 2.78 (Standard Deviation 1.29).
- Tailored Counseling & Navigation (TCN): mean 3.44 (Standard Deviation 1.46).
Logistic regression analyses for intervention effects on CGRA within 6 months yielded the following results:
- For Tailored Print (TP) versus Tailored Counseling and Navigation (TCN), the Odds Ratio (OR) was 6.2 (95% CI: 2.5, 15.2), with a p-value of 0.0001.
- For Usual Care (UC) versus Tailored Counseling and Navigation (TCN), the Odds Ratio (OR) was 7.4 (95% CI: 2.8, 19.4), with a p-value of 0.0001.
- For Usual Care (UC) versus Tailored Print (TP), the Odds Ratio (OR) was 1.2 (95% CI: 0.4, 4.0), with a p-value of 1.2.
What this means
The results indicate that the tailored counseling and navigation (TCN) intervention significantly increases the uptake of medically verified cancer genetic risk assessment compared to both usual care and the tailored print intervention. The strong odds ratios and highly significant p-values (0.0001) suggest that personalized, telephone-based counseling and navigation is an effective strategy to encourage individuals at risk for breast and ovarian cancer to undergo genetic testing. While the tailored print intervention showed a slight increase over usual care, it was not statistically significant. This highlights the potential for comprehensive, individualized support in improving patient engagement with crucial preventative health measures.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03326713, titled "Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project", were posted on 2025-05-28 on clinicaltrials.gov.