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

NCT03326713CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Rutgers, The State University of New Jersey

Enrollment

668

Start Date

2017-11-02

Completion Date

2022-06-02

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Telephone Counseling & Navigation (TCN)Mailed Targeted Print (TP)Usual Care (UC)

Conditions

Breast CancerOvarian Cancer

Eligibility

Age Range

21 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.

Secondary Outcomes

Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months

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.

Time frame: 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

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.

Time frame: 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

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).

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

Locations

Rutgers University, New Brunswick, United States

Linked Papers

2023-02-14

Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow

PURPOSECancer genetic risk assessment (CGRA) is recommended for women with ovarian cancer or high-risk breast cancer, yet fewer than 30% receive recommended genetic services, with the lowest rates among underserved populations. We hypothesized that compared with usual care (UC) and mailed targeted print (TP) education, CGRA uptake would be highest among women receiving a phone-based tailored risk counseling and navigation intervention (TCN).METHODSIn this three-arm randomized trial, women with ovarian or high-risk breast cancer were recruited from statewide cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TP received a mailed educational brochure. Participants assigned to TCN received the mailed educational brochure, an initial phone-based psychoeducational session with a health coach, a follow-up letter, and a follow-up navigation phone call.RESULTSParticipants' average age was 61 years, 25.4% identified as Hispanic, 5.9% identified as non-Hispanic Black, and 17.5% lived in rural areas. At 6 months, more women in TCN received CGRA (18.7%) than those in TP (3%; odds ratio, 7.4; 95% CI, 3.0 to 18.3; P < .0001) or UC (2.5%; odds ratio, 8.9; 95% CI, 3.4 to 23.5; P < .0001). There were no significant differences in CGRA uptake between TP and UC. Commonly cited barriers to genetic counseling were lack of provider referral (33.7%) and cost (26.5%), whereas anticipated difficulty coping with test results (14.0%) and cost (41.2%) were barriers for genetic testing.CONCLUSIONTCN increased CGRA uptake in a group of geographically and ethnically diverse high-risk breast and ovarian cancer survivors. Remote personalized interventions that incorporate evidence-based health communication and behavior change strategies may increase CGRA among women recruited from statewide cancer registries.

Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up

Abstract Purpose Cancer genetic risk assessment (CGRA) is recommended for women with ovarian and high-risk breast cancer. However, the underutilization of CGRA has long been documented, and cost has been a major barrier. In this randomized controlled trial, a tailored counseling and navigation (TCN) intervention significantly improved CGRA uptake at 6-month follow-up, compared with targeted print (TP) and usual care (UC). We aimed to examine the effect of removing genetic counseling costs on CGRA uptake by 12 months. Methods We recruited racially and geographically diverse women with breast and ovarian cancer from cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TCN received telephone-based psychoeducation and navigation. After 6 months, the trial provided free genetic counseling to participants in all arms. Results At 12 months, more women in TCN obtained CGRA (26.6%) than those in TP (11.0%; odds ratio [OR] = 2.77, 95% confidence interval [CI] = 1.56 to 4.89) and UC (12.2%; OR = 2.46, 95% CI = 1.41 to 4.29). There were no significant differences in CGRA uptake between TP and UC. The Kaplan-Meier curve shows that the divergence of cumulative incidence slopes (TCN vs UC, TCN vs TP) appears primarily within the initial 6 months. Conclusion TCN significantly increased CGRA uptake at the 12-month follow-up. Directly removing the costs of genetic counseling attenuated the effects of TCN, highlighting the critical enabling role played by cost coverage. Future policies and interventions should address multilevel cost-related barriers to expand patients’ access to CGRA. Trial Registration This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT03326713. https://clinicaltrials.gov/ct2/show/NCT03326713.

Linked Investigators

Anita Y. Kinney

Antoinette Stroup

Arreum Kim

Circe J.G. Le Compte

Denalee O'Malley

Emily Heidt

Jean A. McDougall

Jinghua An

Julianne Ani

Lisa Paddock

Shou-En Lu

Tawny W. Boyce

Yong Lin