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Modified panel-based genetic counseling for ovarian cancer susceptibility: A randomized non-inferiority study

  • Author Footnotes
    1 Authors contributed equally to work.
    Jeanna M. McCuaig
    Footnotes
    1 Authors contributed equally to work.
    Affiliations
    Familial Breast & Ovarian Cancer Clinic, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada

    Molecular Genetics, University of Toronto, Toronto, ON, Canada
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  • Author Footnotes
    1 Authors contributed equally to work.
    Alicia A. Tone
    Footnotes
    1 Authors contributed equally to work.
    Affiliations
    Gynecologic Oncology, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Manjula Maganti
    Affiliations
    Biostatistics, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Author Footnotes
    2 Present affiliation of T Romagnuolo: Department of Gastrointestinal Oncology, Princess Margaret Cancer Centre, Toronto ON, Canada.
    Tina Romagnuolo
    Footnotes
    2 Present affiliation of T Romagnuolo: Department of Gastrointestinal Oncology, Princess Margaret Cancer Centre, Toronto ON, Canada.
    Affiliations
    Gynecologic Oncology, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Author Footnotes
    3 Present affiliation of N Ricker: Ozmosis Research Inc., Toronto ON, Canada.
    Nicole Ricker
    Footnotes
    3 Present affiliation of N Ricker: Ozmosis Research Inc., Toronto ON, Canada.
    Affiliations
    Gynecologic Oncology, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Jennifer Shuldiner
    Affiliations
    Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
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  • Gary Rodin
    Affiliations
    Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada

    Supportive Care, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Tracy Stockley
    Affiliations
    Advanced Molecular Diagnostics Laboratory, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada

    Clinical Laboratory Genetics, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Raymond H. Kim
    Affiliations
    Familial Breast & Ovarian Cancer Clinic, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
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  • Marcus Q. Bernardini
    Correspondence
    Corresponding author at: Princess Margaret Cancer Centre, Rm 6-812, 700 University Avenue, Toronto, ON M5G1Z5, Canada.
    Affiliations
    Gynecologic Oncology, Princess Margaret Cancer Centre, The University Health Network, Toronto, ON, Canada
    Search for articles by this author
  • Author Footnotes
    1 Authors contributed equally to work.
    2 Present affiliation of T Romagnuolo: Department of Gastrointestinal Oncology, Princess Margaret Cancer Centre, Toronto ON, Canada.
    3 Present affiliation of N Ricker: Ozmosis Research Inc., Toronto ON, Canada.
Published:January 10, 2019DOI:https://doi.org/10.1016/j.ygyno.2018.12.027

      Highlights

      • We evaluated a modified pre-test genetic counseling (GC) model for women undergoing panel-based genetic testing.
      • Time spent with a genetic counselor was shorter in the modified pre-test GC compared to traditional pre-test GC.
      • Modified pre-test GC was non-inferior to traditional GC on psychosocial outcomes, ovarian cancer knowledge and satisfaction.
      • Our modified pre-test GC model provides an efficient and efficacious alternative for individuals undergoing panel testing.
      • Further research in a more diverse population and individuals being referred for clinical pre-test GC is needed.

      Abstract

      Objective

      Genetic testing identifies cancer patients who may benefit from targeted treatment and allows for enhanced cancer screening and risk-reduction in their at-risk relatives. Traditional models of genetic counseling (GC) cannot meet the increasing demand and urgency for genetic testing. The objective of this study was to evaluate a new model of service delivery to improve the efficiency of pre-test GC for panel-based genetic testing.

      Methods

      A parallel, two-armed, randomized non-inferiority study compared traditional and modified pre-test GC models (1:2) prior to panel-based genetic testing. Participants were adult females, whose first-degree relative died of serous ovarian cancer. In the modified group, participants were emailed a 20-minute presentation prior to a scheduled pre-test GC telephone call. Psychosocial and knowledge questionnaires were provided at baseline (P1) and one week after pre-test GC (P2).

      Results

      382 women completed pre-test GC (256 modified, 126 traditional). There were no differences in marital status, education level or household income. Pre-test GC time was shorter in the modified group (average 19 vs. 46 min, p < 0.001), with no difference in post-test GC time (average 16 min each, p = 0.78). The modified pre-test GC model was found to be non-inferior to traditional GC on measures of cancer-specific distress, depression, anxiety, decisional conflict, ovarian cancer knowledge and satisfaction. Perceived lifetime risk for ovarian cancer decreased to a lesser extent from baseline in women who received modified pre-test GC.

      Conclusions

      A 20-minute presentation prior to pre-test telephone GC is non-inferior to traditional in-person GC on all variables tested, except for perceived ovarian cancer risk. This modified model improved GC efficiency without negatively affecting psychosocial outcomes, providing an alternative strategy to meet the growing demand for genetic testing.

      Keywords

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