Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT05325151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D005817', 'term': 'Genetic Counseling'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 874}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Genetic counseling preferences', 'timeFrame': 'Up to 14 months', 'description': 'Will estimate the proportion of subjects who choose the remote (versus in-person) mode of the GCCP stratified by detection of high-risk variants, and construct 95% two-sided confidence intervals.'}], 'primaryOutcomes': [{'measure': 'Adherence to National Comprehensive Cancer Network (NCCN) guidelines of having a clinical encounter every 6-12 months', 'timeFrame': 'Up to 14 months', 'description': 'Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of genetic counseling patient preference (GCCP) versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.'}, {'measure': 'Adherence to NCCN guidelines of having an annual mammogram (and breast magnetic resonance imaging [MRI] with contrast if recommended)', 'timeFrame': 'Up to 14 months', 'description': 'Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin. Will use mixed effects logistic regression with adherence as the outcome, random intercept effects for genetic counselors, and fixed effects for study arm, breast cancer knowledge, breast cancer worry, post-test/counseling distress, and perception of breast cancer risk.'}, {'measure': 'Risk perception', 'timeFrame': 'Up to 14 months', 'description': 'Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.'}, {'measure': 'Breast cancer-specific worry', 'timeFrame': 'Up to 14 months', 'description': 'Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.'}, {'measure': 'Post-test/counseling distress', 'timeFrame': 'Up to 14 months', 'description': 'Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.'}, {'measure': 'Satisfaction with counseling', 'timeFrame': 'Up to 14 months', 'description': 'Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling. Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.'}], 'secondaryOutcomes': [{'measure': 'Adherence to other National Comprehensive Cancer Network (NCCN) recommended cancer screening (e.g. colorectal cancer screening)', 'timeFrame': 'Up to 14 months', 'description': 'Non-inferiority will be assessed by constructing a one-sided 95% confidence interval for the effect of GCCP versus conventional counseling and comparing the bound to a non-inferiority margin.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37661005', 'type': 'DERIVED', 'citation': 'Sweet K, Reiter PL, Schnell PM, Senter L, Shane-Carson KP, Aeilts A, Cooper J, Spears C, Brown J, Toland AE, Agnese DM, Katz ML. Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention. Contemp Clin Trials. 2023 Oct;133:107323. doi: 10.1016/j.cct.2023.107323. Epub 2023 Sep 1.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. Determine the efficacy of genetic counseling patient preference (GCPP) compared to conventional genetic counseling for adherence to National Comprehensive Cancer Network (NCCN) guidelines for having: 1) a clinical encounter every 6-12 months; and 2) an annual mammogram (and breast magnetic resonance imaging \\[MRI\\] with contrast if recommended).\n\nII. Determine the efficacy of the GCPP compared to conventional genetic counseling for adherence to other NCCN recommended cancer screening (e.g. colorectal cancer screening).\n\nIII. Determine the efficacy of the GCPP compared to conventional genetic counseling on breast cancer genetic knowledge, the accurate perception of breast cancer risk, breast cancer-specific worry, post-test/counseling distress, and satisfaction with counseling.\n\nEXPLORATORY OBJECTIVE:\n\nI. Explore the genetic counseling preferences among the GCPP group.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive GCPP intervention which uses REDCap and the MyChart patient portal to: 1) deliver a series of educational videos on pre-genetic test information; 2) provide multigene and polygenic risk score (PRS) test results; 3) obtain information about patients' questions/concerns about test results to use in post-genetic test counseling; and 4) determine patient preference (e.g. telehealth) for receipt of post-genetic test counseling.\n\nARM II: Patients receive conventional genetic counseling with utilization of multigene and polygenic risk score (PRS) test results."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being female.\n* Ages 30-64.\n* Being an Ohio State University (OSU) patient who uses MyChart.\n* Undergoing routine screening mammography.\n* Normal BI-RADS1.\n* At elevated breast cancer risk by the Cancer Risk Assessment (CRA) tool.\n* Able to read and speak English.\n* Provide consent.\n\nExclusion Criteria:\n\n* Previous genetic counseling.\n* Previous genetic testing for cancer risk or known mutation in a breast cancer gene: ATM, BARD1, BRCA1, BRCA2, CDH1, CHEK2, NBN, PALB2, PTEN, TP53.\n* Previous diagnosis of breast or ovarian cancer or personal history of lobular carcinoma in situ (LCIS) or breast hyperplasia (with or without atypia).\n* Being a member of a focus group that assisted with the development of the intervention.'}, 'identificationModule': {'nctId': 'NCT05325151', 'briefTitle': 'Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer', 'orgStudyIdInfo': {'id': 'OSU-22013'}, 'secondaryIdInfos': [{'id': 'NCI-2022-01136', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'R01CA248739', 'link': 'https://reporter.nih.gov/quickSearch/R01CA248739', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (GCPP intervention)', 'description': 'Patients receive GCPP intervention consisting of a series of educational videos on pre-genetic test information.', 'interventionNames': ['Other: Educational Intervention', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (conventional genetic counseling)', 'description': 'Patients receive conventional genetic counseling.', 'interventionNames': ['Other: Genetic Counseling', 'Other: Survey Administration']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive GCPP intervention videos', 'armGroupLabels': ['Arm I (GCPP intervention)']}, {'name': 'Genetic Counseling', 'type': 'OTHER', 'description': 'Receive genetic counseling', 'armGroupLabels': ['Arm II (conventional genetic counseling)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (GCPP intervention)', 'Arm II (conventional genetic counseling)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Kevin Sweet, MS, LGC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kevin Sweet', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}