2024
TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing
Loeb S, Keith S, Cheng H, Leader A, Gross L, Nolasco T, Byrne N, Hartman R, Brown L, Pieczonka C, Gomella L, Kelly W, Lallas C, Handley N, Mille P, Mark J, Brown G, Chopra S, McClellan A, Wise D, Hollifield L, Giri V. TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing. JCO Precision Oncology 2024, 8: e2300552. PMID: 38452310, PMCID: PMC10939575, DOI: 10.1200/po.23.00552.Peer-Reviewed Original ResearchConceptsGermline genetic testingDecisional conflictGenetic counselingProstate cancerPatient-drivenShortage of genetic counselorsKnowledge of cancer geneticsHereditary cancer riskReduce decisional conflictDecisional Conflict ScalePrimary outcome dataMixed-effects regression modelsDiverse patient populationsGenetic servicesClinical trial eligibilityGenetic counselorsGenetics educationPatient experienceCancer riskGermline testingAnalytical data setsCancer geneticsGermline evaluationConflict ScaleGenetic testing
2023
Technology-enhanced acceleration of germline evaluation for therapy (TARGET): Results of a randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing.
Giri V, Keith S, Cheng H, Leader A, Gross L, Sanchez Nolasco T, Byrne N, Hartman R, Brown L, Pieczonka C, Gomella L, Kelly W, Lallas C, Handley N, Mille P, Mark J, Brown G, Chopra S, McClellan A, Loeb S. Technology-enhanced acceleration of germline evaluation for therapy (TARGET): Results of a randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing. Journal Of Clinical Oncology 2023, 41: 10598-10598. DOI: 10.1200/jco.2023.41.16_suppl.10598.Peer-Reviewed Original ResearchDecisional conflictGenetic testingPre-test genetic counselingGermline testingGenetic counselingProstate cancerRandomized non-inferiority trialHereditary cancer risk assessmentGermline genetic testingClinical trial eligibilityNon-inferiority trialProstate Cancer FoundationProstate cancer managementCancer genetic testingDecision Conflict ScaleCancer risk assessmentGermline evaluationTrial eligibilityPrimary endpointMean ageStudy protocolCancer managementGenetics educationAnalysis of covarianceCancer Foundation
2022
Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing
Loeb S, Cheng H, Leader A, Gross L, Nolasco T, Byrne N, Wise D, Hollifield L, Brown L, Slater E, Pieczonka C, Gomella L, Kelly W, Trabulsi E, Handley N, Lallas C, Chandrasekar T, Mille P, Mann M, Mark J, Brown G, Chopra S, Wasserman J, Phillips J, Somers P, Giri V. Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing. Contemporary Clinical Trials 2022, 119: 106821. PMID: 35710085, DOI: 10.1016/j.cct.2022.106821.Peer-Reviewed Original ResearchConceptsKey patient-reported outcomesGermline testingPatient-reported outcomesProstate cancerGenetic counselingCollaborative care strategiesProstate cancer careTwo-armed randomizedProstate Cancer FoundationEducation/counselingGermline evaluationGOV IDENTIFIERPrimary outcomeSecondary outcomesStudy armsTarget enrollmentAshkenazi Jewish ancestryCancer careFamily historyTumor featuresCancer FoundationCare strategiesDecisional conflictUS sitesPractice settingsPatient-reported outcomes among males undergoing prostate cancer germline testing: Interim results from the Prostate Cancer Genetic Risk, Experience, and Support Study (PROGRESS) Registry.
Giri V, Hartman R, Gross L, Keith S. Patient-reported outcomes among males undergoing prostate cancer germline testing: Interim results from the Prostate Cancer Genetic Risk, Experience, and Support Study (PROGRESS) Registry. Journal Of Clinical Oncology 2022, 40: 10595-10595. DOI: 10.1200/jco.2022.40.16_suppl.10595.Peer-Reviewed Original ResearchPatient-reported outcomesGermline testingGenetic testingPROGRESS registryDecisional conflictNon-Hispanic/LatinoDiagnosis of PCaCancer genetic riskGenetic counselingCancer geneticsPatient experience informationStudy registryGleason scoreRegistry participantsFamily historyRegistryGenetic resultsAfrican American malesCategorical variablesGenetic riskSAS 9.4Traditional genetic counselingDemographic informationGenetic mutationsMen
2021
Pretest Genetic Education Video Versus Genetic Counseling for Men Considering Prostate Cancer Germline Testing: A Patient-Choice Study to Address Urgent Practice Needs
Russo J, McDougall C, Bowler N, Shimada A, Gross L, Hyatt C, Kelly W, Calvaresi A, Handley N, Hirsch I, Izes J, Lallas C, Mann M, Mark J, Mille P, Preate D, Trabulsi E, Tsang M, Chandrasekar T, Weiner P, Gomella L, Giri V. Pretest Genetic Education Video Versus Genetic Counseling for Men Considering Prostate Cancer Germline Testing: A Patient-Choice Study to Address Urgent Practice Needs. JCO Precision Oncology 2021, 5: 1377-1386. PMID: 34589662, PMCID: PMC8462590, DOI: 10.1200/po.21.00238.Peer-Reviewed Original ResearchConceptsGermline testingProstate cancerGenetic counselingDecisional conflictComparable patient-reported outcomesHereditary cancer assessmentPatient-reported outcomesCancer genetics knowledgePCa diagnosisPractice settingsPrecision careCancer assessmentInformed consentCategorical variablesSubstantial proportionGenetic knowledgeSignificant differencesContinuous variablesHigh rateMenPractice needsDescriptive statisticsProstate oncologyOutcomesCounseling
2020
Video vs. in-person genetic counseling for men considering germline prostate cancer testing: A patient-choice study.
Giri V, Bowler N, Hegarty S, Gross L, Hyatt C, Kelly W, Gomella L. Video vs. in-person genetic counseling for men considering germline prostate cancer testing: A patient-choice study. Journal Of Clinical Oncology 2020, 38: 1577-1577. DOI: 10.1200/jco.2020.38.15_suppl.1577.Peer-Reviewed Original ResearchCancer genetics knowledgeGermline testingPerson genetic counselingProstate cancerGenetic counselingBaseline anxietyDecisional conflictPatient-reported outcomesAfrican American raceProstate cancer testingHigh baseline anxietyLow educational levelFisher's exactFamily historyPCa diagnosisCancer testingAmerican raceCategorical variablesFirst cohortPathogenic mutationsLow knowledgeSAS 9.4Chi-squaredSubstantial proportionMen
2016
Decision Support and Shared Decision Making About Active Surveillance Versus Active Treatment Among Men Diagnosed with Low-Risk Prostate Cancer: a Pilot Study
Myers R, Leader A, Censits J, Trabulsi E, Keith S, Petrich A, Quinn A, Den R, Hurwitz M, Lallas C, Hegarty S, Dicker A, Zeigler-Johnson C, Giri V, Ayaz H, Gomella L. Decision Support and Shared Decision Making About Active Surveillance Versus Active Treatment Among Men Diagnosed with Low-Risk Prostate Cancer: a Pilot Study. Journal Of Cancer Education 2016, 33: 180-185. PMID: 27418065, DOI: 10.1007/s13187-016-1073-7.Peer-Reviewed Original ResearchConceptsLow-risk prostate cancerActive surveillanceProstate cancerDecision support interventionsActive treatmentDecisional conflictClinic visitsTreatment choiceClinician supportTreatment knowledgePatient choiceSupport interventionsBaseline surveyPilot studyCancerMenTreatmentParticipantsSurveillancePatientsFollowCliniciansSDMVisits