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NCT Number: NCT03326713

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

New Brunswick, New Jersey, 08901, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Colorado Department of Public Health and Environment
  • University of New Mexico

Registry information

Official study title

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

Acronym: GRACE

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2017
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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