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

NCT03326713 | Completed Results DMC

• 1 other identifier: Pro2018001350
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Genetic Testing; Prevention

Outcome Measures

Primary Outcomes (1)

• Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months

  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 Outcomes (3)

• Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months

  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

  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

  1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.

Study Arms (3)

Telephone Counseling & Navigation (TCN)

EXPERIMENTAL

Telephone Counseling

Behavioral: Telephone Counseling & Navigation (TCN)

Mailed Targeted Print (TP)

ACTIVE COMPARATOR

Mailed Targeted Print

Behavioral: Mailed Targeted Print (TP)

Usual Care (UC)

OTHER

Control

Other: Usual Care (UC)

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.

Telephone Counseling & Navigation (TCN)

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.

Mailed Targeted Print (TP)

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.

Usual Care (UC)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast Cancer
• Hispanic or non-Hispanic
• Female
• 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
• years of age or older
• English-speaking
• History of ovarian, fallopian, or peritoneal cancer diagnosed at any age

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Colorado Department of Public Health and Environment: collaborator
• University of New Mexico: collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (5)

• An J, McDougall J, Lin Y, Lu SE, Walters ST, Heidt E, Stroup A, Paddock L, Grumet S, Toppmeyer D, Kinney AY. Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up. JNCI Cancer Spectr. 2024 Feb 29;8(2):pkae018. doi: 10.1093/jncics/pkae018.

  PMID: 38490263 DERIVED

• Kinney AY, Walters ST, Lin Y, Lu SE, Kim A, Ani J, Heidt E, Le Compte CJG, O'Malley D, Stroup A, Paddock LE, Grumet S, Boyce TW, Toppmeyer DL, McDougall JA. Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow. J Clin Oncol. 2023 May 20;41(15):2767-2778. doi: 10.1200/JCO.22.00751. Epub 2023 Feb 14.

  PMID: 36787512 DERIVED

• Le Compte CG, Lu SE, Ani J, McDougall J, Walters ST, Toppmeyer D, Boyce TW, Stroup A, Paddock L, Grumet S, Lin Y, Heidt E, Kinney AY. Understanding cancer genetic risk assessment motivations in a remote tailored risk communication and navigation intervention randomized controlled trial. Health Psychol Behav Med. 2022 Dec 9;10(1):1190-1215. doi: 10.1080/21642850.2022.2150623. eCollection 2022.

  PMID: 36518606 DERIVED

• Kinney AY, Blair CK, Guest DD, Ani JK, Harding EM, Amorim F, Boyce T, Rodman J, Ford CG, Schwartz M, Rosenberg L, Foran O, Gardner J, Lin Y, Arap W, Irwin MR. Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial. Contemp Clin Trials Commun. 2019 Aug 21;16:100431. doi: 10.1016/j.conctc.2019.100431. eCollection 2019 Dec.

  PMID: 31650067 DERIVED

• Kinney AY, Howell R, Ruckman R, McDougall JA, Boyce TW, Vicuna B, Lee JH, Guest DD, Rycroft R, Valverde PA, Gallegos KM, Meisner A, Wiggins CL, Stroup A, Paddock LE, Walters ST. Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial. Contemp Clin Trials. 2018 Oct;73:123-135. doi: 10.1016/j.cct.2018.09.005. Epub 2018 Sep 18.

  PMID: 30236776 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Anita Y. Kinney, PhD
• Organization: Rutgers Cancer Institute

anita.kinney@rutgers.edu

(732) 865-3375

Study Officials

• Anita Y Kinney, PhD, RN

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator; Associate Director for Cancer Health Equity

Model Details: 3-arm Randomized Controlled Trial

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 31, 2017
• Study Start: November 2, 2017
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)