Evidence map›Paper›PMID 37661005›Full record

ArticleContemporary clinical trials2023

Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention.

Kevin Sweet, Paul L Reiter, Patrick M Schnell, Leigha Senter, Kate P Shane-Carson, Amber Aeilts, Julia Cooper, Christina Spears, Jordan Brown, Amanda E Toland and 2 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kevin SweetDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA. Electronic address: kevin.sweet@osumc.edu.
Paul L ReiterComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, OH, USA.
Patrick M SchnellComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH, USA.
Leigha SenterDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Kate P Shane-CarsonDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Amber AeiltsDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Julia CooperDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Christina SpearsDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
Jordan BrownDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Bioethics, Department of Biomedical Education and Anatomy, The Ohio State University, Columbus, OH, USA.
Amanda E TolandDivision of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Department of Cancer Biology and Genetics, College of Medicine, The Ohio State University, Columbus, OH, USA.
Doreen M AgneseComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Department of Surgery, College of Medicine, The Ohio State University, Columbus, OH, USA.
Mira L KatzComprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, OH, USA.

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve HealthUL1TR002733 · NCATS · OHIO STATE UNIVERSITY · PI RINGEL, MATTHEW D · 2018 to 2022
$28.9M
A Randomized Controlled Trial: Genetic Counseling Patient Preference Intervention via Electronic Health Record Portal vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast CancerR01CA248739 · NCI · OHIO STATE UNIVERSITY · PI KATZ, MIRA L, SWEET, KEVIN M. · 2021 to 2025
$2.8M
NCATS NIH HHS UL1 TR002733NCI NIH HHS P30 CA016058NCI NIH HHS R01 CA248739
6 · The paper itself

Abstract

backgroundGenetic counseling and testing have an important role in the care of patients at elevated risk for breast cancer. However, conventional pre- and post-test genetic counseling is labor and time intensive, less accessible for patients living outside major urban centers, and impractical on a large scale. A patient-driven approach to genetic counseling and testing may increase access, improve patients' experiences, affect efficiency of clinical practice, and help meet workforce demand. The objective of this 2-arm randomized controlled trial is to determine the efficacy of Know Your Risk (KYR), a genetic counseling patient preference intervention.

methodsFemales (n = 1000) at elevated risk (>20% lifetime) for breast cancer will be randomized to the KYR intervention or conventional genetic counseling. The study will provide comprehensive assessment of breast cancer risk by multigene panel testing and validated polygenic risk score. Primary outcome is adherence to National Comprehensive Cancer Network guidelines for a clinical encounter every 6-12 months and an annual mammogram (breast MRI if recommended) determined by medical record review. Secondary outcomes include adherence to other recommended cancer screening tests determined by medical record review and changes in breast cancer knowledge, perception of risk, post-test/counseling distress, and satisfaction with counseling by completion of three surveys during the study. Study aims will be evaluated for non-inferiority of the KYR intervention compared to conventional genetic counseling.

conclusionIf efficacious, the KYR intervention has the potential to improve patients' experience and may change how genetic counseling is delivered, inform best practices, and reduce workforce burden.

trial registrationClinicalTrials.govNCT05325151.

Indexed as

Breast NeoplasmsGenetic CounselingCounselingFemaleGenetic TestingHumansRandomized Controlled Trials as TopicRisk FactorsBreast cancerGenetic counselingGenetic testingPatient educationPolygenicRandomized controlled trial

Identifiers

PMID37661005
PMCPMC10591709

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.