Clinical trial · Interventional
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project
Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
NCT03326713CI-TRIAL-00115935GRACEcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mailed Targeted Print (TP) | Behavioral | — | UNRESOLVED |
| Telephone Counseling & Navigation (TCN) | Behavioral | — | UNRESOLVED |
| Usual Care (UC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Telephone Counseling & Navigation (TCN)
- description
- Telephone Counseling
- interventionNames
- Behavioral: Telephone Counseling & Navigation (TCN)
- type
- ACTIVE_COMPARATOR
- label
- Mailed Targeted Print (TP)
- description
- Mailed Targeted Print
- interventionNames
- Behavioral: Mailed Targeted Print (TP)
- type
- OTHER
- label
- Usual Care (UC)
- description
- Control
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (5)
- DERIVEDAn J, McDougall J, Lin Y, Lu SE, Walters ST, Heidt E, Stroup A, Paddock L, Grumet S, Toppmeyer D, Kinney AY. Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up. JNCI Cancer Spectr. 2024 Feb 29;8(2):pkae018. doi: 10.1093/jncics/pkae018. PMID 38490263
- DERIVEDKinney AY, Walters ST, Lin Y, Lu SE, Kim A, Ani J, Heidt E, Le Compte CJG, O'Malley D, Stroup A, Paddock LE, Grumet S, Boyce TW, Toppmeyer DL, McDougall JA. Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow. J Clin Oncol. 2023 May 20;41(15):2767-2778. doi: 10.1200/JCO.22.00751. Epub 2023 Feb 14. PMID 36787512
- DERIVEDLe Compte CG, Lu SE, Ani J, McDougall J, Walters ST, Toppmeyer D, Boyce TW, Stroup A, Paddock L, Grumet S, Lin Y, Heidt E, Kinney AY. Understanding cancer genetic risk assessment motivations in a remote tailored risk communication and navigation intervention randomized controlled trial. Health Psychol Behav Med. 2022 Dec 9;10(1):1190-1215. doi: 10.1080/21642850.2022.2150623. eCollection 2022. PMID 36518606
- DERIVEDKinney AY, Blair CK, Guest DD, Ani JK, Harding EM, Amorim F, Boyce T, Rodman J, Ford CG, Schwartz M, Rosenberg L, Foran O, Gardner J, Lin Y, Arap W, Irwin MR. Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial. Contemp Clin Trials Commun. 2019 Aug 21;16:100431. doi: 10.1016/j.conctc.2019.100431. eCollection 2019 Dec. PMID 31650067
- DERIVEDKinney AY, Howell R, Ruckman R, McDougall JA, Boyce TW, Vicuna B, Lee JH, Guest DD, Rycroft R, Valverde PA, Gallegos KM, Meisner A, Wiggins CL, Stroup A, Paddock LE, Walters ST. Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial. Contemp Clin Trials. 2018 Oct;73:123-135. doi: 10.1016/j.cct.2018.09.005. Epub 2018 Sep 18. PMID 30236776