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

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.

Conditions

• Breast Cancer
• Ovarian Cancer

Interventions

BEHAVIORAL

Telephone Counseling & Navigation (TCN)

A health coach will conduct a 30-45 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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Colorado Department of Public Health and Environment

  collaborator OTHER_GOV

• University of New Mexico

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Anita Y Kinney, PhD, RN · Rutgers, The State University of New Jersey

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-02

Primary Completion

2022-06-02

Completion

2022-06-02

Countries

• United States

Study Locations