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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

Conditions
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Breast Cancer, Ovarian Cancer

Intervention / Treatment
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* Behavioral: Telephone Counseling & Navigation (TCN)
* Behavioral: Mailed Targeted Print (TP)
* Other: Usual Care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Breast cancer survivor eligibility: Inclusion 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 Exclusion • Have had prior genetic counseling or testing for hereditary breast and/or Ovarian cancer survivor eligibility: Inclusion 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 • Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Counseling & Navigation (TCN)<br>Telephone Counseling | Behavioral: Telephone Counseling & Navigation (TCN)<br>* A health coach will conduct a 15-30 minute telephone counseling session with participants. Prior to the telephone session, participants will receive the same brochure that the TP arm receives. After the phone call, participants will receive a tailored follow-up letter which will include images tailored to the individual's age, self-identified ethnicity, and family composition.<br>|
| Active Comparator: Mailed Targeted Print (TP)<br>Mailed Targeted Print | Behavioral: Mailed Targeted Print (TP)<br>* Participants will be mailed an educational brochure within two weeks of completing the baseline survey that addresses important evidence-based theoretical targets: CGRA guideline (knowledge), threat appraisal (to validate or raise risk perceptions, HBOC seriousness), response efficacy (benefits and expectations about CGRA), self-efficacy messages (CGRA resources, insurance reimbursement, and assistance for those with financial challenges) and possible actions to take (make an appointment and discuss with provider). Both the targeted print and tailored intervention materials were developed using formative community engaged research methods.<br>|
| Other: Usual Care (UC)<br>Control | Other: Usual Care (UC)<br>* A usual care arm is included to assess CGRA uptake in the absence of intervention as well as priming from the surveys for the primary outcome analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Genetic Risk Assessment (Genetic Counseling) CGRA | 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. | 1 month, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict for CGRA: SURE Scale | 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. | 1 month; 6 months; or 12 months | 
| Cancer Genetic Risk Assessment Intention | 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 | Baseline; 1 month; 6 months; or 12 months | 
| HBOC Genetic Testing Intention | 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 | Baseline; 1 month; 6 months; or 12 months | 
| HBOC Genetic Testing Uptake | 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. | 1 month; 6 months; or 12 months | 
| Decisional conflict for HBOC genetic testing: Low Literacy Decisional Conflict Scale (DCS) SURE Scale | 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. | 6 months; or 12 months | 
| Decisional satisfaction with CGRA: Satisfaction with Decision Instrument | 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. | 6 months; or 12 months | 
| Decision Regret Scale | 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. | 6 months; or 12 months | 
| CGRA and HBOC Genetic Testing Facilitators | Questionnaire: Facilitators include but are not limited to: help from family, desire to reduce risk of second cancers, and help/referrals from medical professionals. | Baseline; 1 month; 6 months; or 12 months | 
| Cost Data | 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. | 6 Months and 12 months | 
| Physician/Health Care Provider Recommendation and Communication | 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. | Baseline; 1 month; 6 months; or 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic Testing, Prevention