Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project
- Conditions
- Breast CancerOvarian Cancer
- Interventions
- Behavioral: Mailed Targeted Print (TP)Other: Usual Care (UC)Behavioral: Telephone Counseling & Navigation (TCN)
- Registration Number
- NCT03326713
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 668
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
Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 Cancer Genetic Risk Assessment (Genetic Counseling) CGRA 1 month, 6 months, and 12 months Questionnaire: Participants will be asked whether they have had CGRA, the provider who conducted the CGRA, and the provider's genetics training. CGRA will be medical record verified delivered by the 6-month follow-up.
- Secondary Outcome Measures
Name Time Method HBOC Genetic Testing Intention Baseline; 1 month; 6 months; or 12 months Questionnaire: One item will measure future intention to get genetic testing for HBOC. In follow up surveys, this will only be asked if participant does not report uptake of genetic testing
Cancer Genetic Risk Assessment Intention Baseline; 1 month; 6 months; or 12 months Questionnaire: One item will measure future intention to get cancer genetic risk assessment. In follow up surveys, this will only be asked if participant does not report uptake of CGRA
HBOC Genetic Testing Uptake 1 month; 6 months; or 12 months Questionnaire: Participants will be asked if they received the intervention brochure and had telephone coaching. If yes, they will be asked questions regarding their reaction to the intervention.
Decisional conflict for CGRA: SURE Scale 1 month; 6 months; or 12 months Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale. Range from 0-4, with 0 indicating high decisional conflict.
CGRA and HBOC Genetic Testing Facilitators Baseline; 1 month; 6 months; or 12 months Questionnaire: Facilitators include but are not limited to: help from family, desire to reduce risk of second cancers, and help/referrals from medical professionals.
Decisional conflict for HBOC genetic testing: Low Literacy Decisional Conflict Scale (DCS) SURE Scale 6 months; or 12 months Questionnaire: Decisional conflict associated with the HBOC gene test decision will be measured separately with 4 items using the SURE SCALE. Sum the four responses. Range from 0-4, with 0 indicating high decisional conflict.
Decisional satisfaction with CGRA: Satisfaction with Decision Instrument 6 months; or 12 months Questionnaire: Decisional satisfaction will be assessed using the Satisfaction with Decision Instrument. Five questions assess their personal satisfaction with their decision and two additional items assess how they feel about their CGRA decision in relation to their family. Satisfaction Score: Range 5-25, with 25 indicating high decisional satisfaction. Family Score: Range 2-10, with 10 indicating high consistency with personal values.
Decision Regret Scale 6 months; or 12 months Questionnaire: Five items will ask about regret regarding the decision to have or not have CGRA. Range from 0-100, with 100 indicating high decisional regret.
Cost Data 6 Months and 12 months Questionnaire: Several items will be used to conduct a cost analysis in terms of costs to participants. These questions were developed for the purpose of this study and include out-of-pocket costs.
Physician/Health Care Provider Recommendation and Communication Baseline; 1 month; 6 months; or 12 months Questionnaire: Will assess whether healthcare providers have discussed participant's risk of HBOC and CGRA, and how participants feel discussing genetic testing with health care provider.
Trial Locations
- Locations (1)
Rutgers University
🇺🇸New Brunswick, New Jersey, United States