Clinical trial NCT03326713: Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project
Official title: Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Keywords: Genetic Testing
Prevention
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Colorado Department of Public Health and Environment
name: University of New Mexico
First posted: 2017-10-31
Enrollment: 668
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm Randomized Controlled Trial
Primary purpose: PREVENTION

Brief 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.

Detailed description: There is increasing evidence that activated and engaged patients who are equipped with necessary skills and information are more likely to follow through with recommended care and have better health outcomes at reduced costs. Identification of individuals at increased risk of hereditary breast and ovarian cancer (HBOC) is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. The primary purpose of this study is to assess the feasibility and acceptability of two remote interventions aimed at promoting cancer genetic risk assessment (CGRA) for HBOC. The randomized controlled trial will have 3 arms: usual care (UC) vs. targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN).

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

Primary outcomes:
measure: Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months
timeFrame: 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.
Secondary outcomes:
measure: Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months
timeFrame: 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.
measure: Decisional Conflict for CGRA: SURE Scale
timeFrame: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.
measure: Cancer Genetic Risk Assessment Intention
timeFrame: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Anita Y Kinney, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kinney 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.
citation: Kinney 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.