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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

668 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2022-06-02

Brief Summary

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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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Detailed Description

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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).

Conditions

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Breast Cancer Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm Randomized Controlled Trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Telephone Counseling & Navigation (TCN)

Telephone Counseling

Group Type EXPERIMENTAL

Telephone Counseling & Navigation (TCN)

Intervention Type 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)

Mailed Targeted Print

Group Type ACTIVE_COMPARATOR

Mailed Targeted Print (TP)

Intervention Type 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)

Control

Group Type OTHER

Usual Care (UC)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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