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

May 12, 2025 updated by: Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

668

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Breast Cancer

  • 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

Ovarian Cancer

  • 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 Criteria:

Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone Counseling & Navigation (TCN)
Telephone Counseling
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.
Active Comparator: Mailed Targeted Print (TP)
Mailed Targeted Print
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)
Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 6-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent allowing research staff to obtain document of receipt of the genetic services.
6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months
Time Frame: 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 12-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent, allowing research staff to obtain documents of receipt of the genetic services.
12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.
Decisional Conflict for CGRA: SURE Scale
Time Frame: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.
Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale (Sure of myself; Understand information; Risk-benefit ratio; Encouragement). Range from 0-4, with 0 indicating high decisional conflict.
1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.
Cancer Genetic Risk Assessment Intention
Time Frame: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.
Questionnaire: One item will measure future intention to get a cancer genetic risk assessment within the next 6 weeks. Responses for this item ranged from 1 (not at all) to 5 (extremely likely).
1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Colorado Department of Public Health and Environment
University of New Mexico

Investigators

  • Principal Investigator: Anita Y Kinney, PhD, RN, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Actual)

June 2, 2022

Study Completion (Actual)

June 2, 2022

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro2018001350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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