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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT03326713
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Telephone Counseling & Navigation (TCN) — BEHAVIORAL
    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.
  • Mailed Targeted Print (TP) — BEHAVIORAL
    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.
  • Usual Care (UC) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 2, 2017
Status verified
May 2025
Primary completion
Jun 2, 2022
Completion
Jun 2, 2022

Study Design

Enrollment
668 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Telephone Counseling & Navigation (TCN)
    Telephone Counseling
  • Active Comparator: Mailed Targeted Print (TP)
    Mailed Targeted Print
  • Other: Usual Care (UC)
    Control

Primary Outcome Measure

Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months [ Time Frame: 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers UniversityNew BrunswickNew Jersey08901-

Find similar trials in New Brunswick, NJ

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
Rutgers University· New Brunswick, NJ

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