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

Breast Cancer Clinical Trial

— GRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326713
• Other study ID #: Pro2018001350
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer

Intervention

Behavioral:
• Telephone Counseling & Navigation (TCN)
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.
• Mailed Targeted Print (TP)
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.

Other:
• Usual Care (UC)
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.

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Colorado Department of Public Health and Environment, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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