Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project

Not Applicable

Completed

Interventions: Behavioral: Mailed Targeted Print (TP)
Other: Usual Care (UC)
Behavioral: Telephone Counseling & Navigation (TCN)

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).

Recruitment & Eligibility

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

Exclusion Criteria

Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer

Arm && Interventions

Group	Intervention	Description
Mailed Targeted Print (TP)	Mailed Targeted Print (TP)	Mailed Targeted Print
Usual Care (UC)	Usual Care (UC)	Control
Telephone Counseling & Navigation (TCN)	Telephone Counseling & Navigation (TCN)	Telephone Counseling

Primary Outcome Measures

Name	Time	Method
Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months	6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.	Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 6-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent allowing research staff to obtain document of receipt of the genetic services.

Secondary Outcome Measures

Name	Time	Method
Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months	12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.	Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 12-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent, allowing research staff to obtain documents of receipt of the genetic services.
Decisional Conflict for CGRA: SURE Scale	1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.	Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale (Sure of myself; Understand information; Risk-benefit ratio; Encouragement). Range from 0-4, with 0 indicating high decisional conflict.
Cancer Genetic Risk Assessment Intention	1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.	Questionnaire: One item will measure future intention to get a cancer genetic risk assessment within the next 6 weeks. Responses for this item ranged from 1 (not at all) to 5 (extremely likely).