Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:38 AM
Study NCT ID:
NCT07471958
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of Visit 1', 'timeFrame': 'Through 6 months', 'description': 'Participant completion of Visit 1 (yes/no)'}, {'measure': 'Uptake of Digital Visit 1', 'timeFrame': 'Through 6 months', 'description': 'Participant completion of digital intervention as an alternative for Visit 1 (yes/no)'}, {'measure': 'Uptake of genetic testing', 'timeFrame': 'Through 6 months', 'description': 'Participant completion of genetic testing and received results/Visit 2 (yes/no)'}], 'secondaryOutcomes': [{'measure': 'The KnowGene Scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Change in Knowledge - Score Range = 0-16, Higher score = Better outcome'}, {'measure': 'Test result recall', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Recall of genetic testing results'}, {'measure': 'Impact of Events Scale (IES)', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Change in Cancer Specific Distress - Score Range = 0-40, Lower score = Better outcome'}, {'measure': 'Satisfaction with genetic services', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Differences in satisfaction - Score Range = 14-70, Higher score = Better outcome'}, {'measure': 'Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Change in Uncertainty - Score Range = 0-85, Lower score = Better outcome'}, {'measure': 'Decisional Regret Scale', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Differences in decisional regret - Score Range = 5-25, Lower score = Better outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to understand patient interest in telehealth and digital tools for pre-test genetic education and/or disclosure of genetic test results. Participants will receive telehealth genetic counseling in the home and may be offered various digital tools to help with the counseling and testing process. These are optional and participants can still speak with a genetic counselor if they wish.', 'detailedDescription': 'The goal of the eREACH3 Study is to evaluate the implementation of these tools into remote genetic services, evaluating uptake and use of digital tools and outcomes in representative clinical populations. The initial protocol will include two genetic counseling visits, providing comparison outcomes. Future amendments will be provided as digital tools are ready for implementation.\n\nSpecific Aim 1: (Reach) Evaluate the uptake, use and acceptability of digital delivery alternatives in remote genetic services provided as alternatives to the traditional two-visit model with a genetic counselor.\n\nSpecific Aim 2: (Effectiveness) Evaluate short-term and 6 month patient reported cognitive, affective and behavioral outcomes (2a) with remote genetic services and digital alternatives in representative clinical populations and moderators of outcomes (2b).\n\nSpecific Aim 3: (Implementation) Evaluate provider time associated with implementation of remote telehealth services and digital delivery alternatives and barriers and facilitators to future clinical implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with personal or family history of cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Speak and understand English\n* Meet current National Comprehensive Cancer Network (NCCN) or other national guidelines for germline genetic testing or are interested in genetic counseling based on personal or family history of cancer. Patients with prior genetic testing are eligible if they meet criteria for updated testing, or if post-test genetic counseling services are requested.\n\nExclusion Criteria:\n\n* Communication difficulties such as:\n* Uncorrected or uncompensated hearing and/or vision impairment. Patients who can successfully use clinical assistance devices are not excluded.\n* Uncorrected or uncompensated speech defects. Patients who can successfully use clinical assistance devices are not excluded.\n* Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks'}, 'identificationModule': {'nctId': 'NCT07471958', 'acronym': 'eREACH3', 'briefTitle': 'Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3)', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3)', 'orgStudyIdInfo': {'id': 'UPCC 12025'}, 'secondaryIdInfos': [{'id': 'IRB#858825', 'type': 'OTHER', 'domain': 'University of Pennsylvania IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Visit 1', 'description': 'All participants will be offered remote telehealth Visit 1 services by telephone or real-time videoconference or by a chatbot (patient choice).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Bradbury, MD', 'role': 'CONTACT', 'email': 'angela.bradbury@pennmedicine.upenn.edu', 'phone': '215-615-3341'}], 'facility': 'Abramson Cancer Center at the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Angela Bradbury, MD', 'role': 'CONTACT', 'email': 'angela.bradbury@pennmedicine.upenn.edu', 'phone': '215-615-3341'}, {'name': 'Kelsey Karpink', 'role': 'CONTACT', 'email': 'kelsey.karpink@pennmedicine.upenn.edu', 'phone': '215-662-3531'}], 'overallOfficials': [{'name': 'Angela Bradbury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}