Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

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.

Telephone Counseling & Navigation (TCN)

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.

Mailed Targeted Print (TP)

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.

Usual Care (UC)

Anita Y Kinney, PhD, RN

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).

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).

Randomization will be single blinded. Research team members who are assessing the outcomes will be blinded to study arm assignment. Research staff who are conducting follow-up interviews will be blinded to group assignment as much as possible. At the beginning of the follow-up interviews, the interviewer will request that the participant does not reveal the study arm they were assigned to.

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

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.

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.

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

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

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.

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.

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.

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.

Questionnaire: Facilitators include but are not limited to: help from family, desire to reduce risk of second cancers, and help/referrals from medical professionals.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project	NCT03326713	Breast Cancer Ovarian Cancer	Telephone Couns... Mailed Targeted... Usual Care (UC)	21 Years -	Rutgers, The State University of New Jersey
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project	NCT03326713	Breast Cancer Ovarian Cancer	Telephone Couns... Mailed Targeted... Usual Care (UC)	21 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for telephone counseling & navigation (tcn)