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

Rutgers The State University of New Jersey

Status: Completed

Conditions: Breast Cancer; Ovarian Cancer

Treatments: Other: Usual Care (UC); Behavioral: Telephone Counseling & Navigation (TCN); Behavioral: Mailed Targeted Print (TP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03326713

Pro2018001350

Details and patient eligibility

About

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.

Full 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).

Enrollment: 668 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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668 participants in 3 patient groups

Telephone Counseling & Navigation (TCN)

Experimental group

Description:

Telephone Counseling

Treatment:

Behavioral: Telephone Counseling & Navigation (TCN)

Mailed Targeted Print (TP)

Active Comparator group

Description:

Mailed Targeted Print

Treatment:

Behavioral: Mailed Targeted Print (TP)

Usual Care (UC)

Other group

Description:

Control

Treatment:

Other: Usual Care (UC)