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

Anita Y. Kinney, Rachel Howell, Rachel Ruckman, Jean A. McDougall, Tawny W. Boyce, Belinda Vicuña, Ji Hyun Lee, Dolores D. Guest, Randi Rycroft, Patricia A. Valverde, Kristina M. Gallegos, Angela Meisner, Charles L. Wiggins, Antoinette Stroup, Lisa E. Paddock, Scott T. Walters

Research output: Contribution to journalArticle

Abstract

Background: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. Methods: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. Discussion: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. Trial registration number: NCT03326713; clinicaltrials.gov.

Original languageEnglish
Pages (from-to)123-135
Number of pages13
JournalContemporary Clinical Trials
Volume73
DOIs
StatePublished - 1 Oct 2018

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Ovarian Neoplasms
Survivors
Randomized Controlled Trials
Guidelines
Breast Neoplasms
Neoplasms
Education
Costs and Cost Analysis
Genetic Counseling
Vulnerable Populations
Rural Population
Early Detection of Cancer
Registries
Counseling
Research

Keywords

  • Assessment risk
  • Genetic counseling
  • Hereditary cancer

Cite this

Kinney, Anita Y. ; Howell, Rachel ; Ruckman, Rachel ; McDougall, Jean A. ; Boyce, Tawny W. ; Vicuña, Belinda ; Lee, Ji Hyun ; Guest, Dolores D. ; Rycroft, Randi ; Valverde, Patricia A. ; Gallegos, Kristina M. ; Meisner, Angela ; Wiggins, Charles L. ; Stroup, Antoinette ; Paddock, Lisa E. ; Walters, Scott T. / 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. In: Contemporary Clinical Trials. 2018 ; Vol. 73. pp. 123-135.
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abstract = "Background: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. Methods: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. Discussion: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. Trial registration number: NCT03326713; clinicaltrials.gov.",
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Kinney, AY, Howell, R, Ruckman, R, McDougall, JA, Boyce, TW, Vicuña, B, Lee, JH, Guest, DD, Rycroft, R, Valverde, PA, Gallegos, KM, Meisner, A, Wiggins, CL, Stroup, A, Paddock, LE & Walters, ST 2018, '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', Contemporary Clinical Trials, vol. 73, pp. 123-135. https://doi.org/10.1016/j.cct.2018.09.005

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. / Kinney, Anita Y.; Howell, Rachel; Ruckman, Rachel; McDougall, Jean A.; Boyce, Tawny W.; Vicuña, Belinda; Lee, Ji Hyun; Guest, Dolores D.; Rycroft, Randi; Valverde, Patricia A.; Gallegos, Kristina M.; Meisner, Angela; Wiggins, Charles L.; Stroup, Antoinette; Paddock, Lisa E.; Walters, Scott T.

In: Contemporary Clinical Trials, Vol. 73, 01.10.2018, p. 123-135.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors

T2 - Rationale and design of a 3-arm randomized controlled trial

AU - Kinney, Anita Y.

AU - Howell, Rachel

AU - Ruckman, Rachel

AU - McDougall, Jean A.

AU - Boyce, Tawny W.

AU - Vicuña, Belinda

AU - Lee, Ji Hyun

AU - Guest, Dolores D.

AU - Rycroft, Randi

AU - Valverde, Patricia A.

AU - Gallegos, Kristina M.

AU - Meisner, Angela

AU - Wiggins, Charles L.

AU - Stroup, Antoinette

AU - Paddock, Lisa E.

AU - Walters, Scott T.

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Background: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. Methods: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. Discussion: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. Trial registration number: NCT03326713; clinicaltrials.gov.

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