[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05427240":3,"trial-entities:NCT05427240":125,"trial-summary:NCT05427240":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":43,"secondary_outcomes":54,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":89,"locations":92,"central_contacts":106,"overall_officials":115,"references":119,"see_also_links":124},"NCT05427240","13021","eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer","A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer","RECRUITING","2026-07-01","2026-01","2026-01-16","2022-09-28","Abramson Cancer Center at Penn Medicine","OTHER",false,"This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.","Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that \\\u003C20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.\n\nThis study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre\u002Fpost-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.",[19],"Cancer",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},1000,"ESTIMATED",[28,34,40],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Pre-Test Intervention","Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.",[32,33],"ARM B","ARM D",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Standard of Care","Standard of Care with a Genetic Counselor by Remote Services",[38,32,39],"ARM A","ARM C",{"type":14,"name":41,"description":30,"armGroupLabels":42},"Post-Test Intervention",[39,33],[44,48,51],{"measure":45,"description":46,"timeFrame":47},"The KnowGene Scale","Change in Knowledge - Score Range = 0-16, Higher score = Better outcome","Through study completion, an average of 1 year",{"measure":49,"description":50,"timeFrame":47},"Patient Reported Outcome Measurement Information System (PROMIS)","Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome",{"measure":52,"description":53,"timeFrame":47},"Uptake of Genetic Services","Testing uptake per arm - Yes\u002FNo",[55,57,60,63,66,69],{"measure":49,"description":56,"timeFrame":47},"Change in General Depression - Score Range = 4-20, Lower score = Better outcome",{"measure":58,"description":59,"timeFrame":47},"Impact of Events Scale (IES)","Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome",{"measure":61,"description":62,"timeFrame":47},"Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)","Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome",{"measure":64,"description":65,"timeFrame":47},"Satisfaction with genetic services","Differences in satisfaction by Arm - Score Range = 14-70, Higher score = Better outcome",{"measure":67,"description":68,"timeFrame":47},"Decisional Regret Scale","Differences in decisional regret by Arm - Score Range = 5-25, Lower score = Better outcome",{"measure":70,"description":71,"timeFrame":47},"Provider Time","Time (minutes) provider spends per patient","ALL","18 Years",null,true,{"inclusion":77,"exclusion":83,"raw_text":88},[78,79,80,81,82],"18 years of age or older","Speak and understand English","Male or Female","No prior germline genetic testing","Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing",[84,85,86,87],"Communication difficulties such as:","Uncorrected or uncompensated hearing and\u002For vision impairment","Uncorrected or uncompensated speech defects","Uncontrolled psychiatric\u002Fmental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks","Inclusion Criteria:\n\n* 18 years of age or older\n* Speak and understand English\n* Male or Female\n* No prior germline genetic testing\n* Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing\n\nExclusion Criteria:\n\n-Communication difficulties such as:\n\n* Uncorrected or uncompensated hearing and\u002For vision impairment\n* Uncorrected or uncompensated speech defects\n* Uncontrolled psychiatric\u002Fmental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":103},"Abramson Cancer Center at the University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",[100],{"name":101,"role":102},"Angela Bradbury, MD","CONTACT",{"lat":104,"lon":105},39.95238,-75.16362,[107,111],{"name":108,"role":102,"phone":109,"email":110},"Angela R Bradbury, MD","215 615 3341","Angela.Bradbury@pennmedicine.upenn.edu",{"name":112,"role":102,"phone":113,"email":114},"Dominique Fetzer, BA","215 662 2753","Dominique.Fetzer@pennmedicine.upenn.edu",[116],{"name":108,"affiliation":117,"role":118},"University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[120],{"pmid":121,"type":122,"citation":123},"41332807","DERIVED","Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): study protocol. medRxiv [Preprint]. 2025 Nov 22:2025.11.19.25340515. doi: 10.1101\u002F2025.11.19.25340515.",[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Malignant Neoplasm",[],{"nct_id":4,"found":75,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This study is a randomized comparison between two different ways of delivering genetic testing information. It plans to include about 1000 participants.","completed","eHealth Delivery for Cancer Genetic Testing","This study is looking at new ways to deliver genetic testing for cancer. It compares the usual way of getting genetic counseling from a genetic counselor (Standard of Care) with a new web-based program (Pre-Test Intervention and Post-Test Intervention). This program would give you your genetic test results and explain what they mean online. The study wants to see if the web-based program works as well as or better than traditional counseling in helping people understand their results, feel less worried, and take steps to reduce their cancer risk. We are looking for about 1000 adults, aged 18 or older, who speak English, have not had genetic testing before, and meet specific guidelines for genetic testing. The study is currently unclear on its recruitment status.","Participants will be followed for about 1 year to measure their understanding, well-being, and use of genetic services.",125,"Not specified in the trial record.","Not stated in the trial record.",[29,35,41],"v2"]