Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00609505
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2008-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine vs. Face-to-Face Cancer Genetic Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-21', 'studyFirstSubmitDate': '2008-01-25', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'One week post-intervention (genetic counseling session)'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': 'Enrollment completion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hereditary Breast and Ovarian Cancer syndrome', 'genetic counseling', 'breast cancer', 'ovarian cancer', 'telemedicine', 'Cancer genetic counseling'], 'conditions': ['Hereditary Breast and Ovarian Cancer Syndrome', 'Lynch Syndrome']}, 'referencesModule': {'references': [{'pmid': '25833335', 'type': 'DERIVED', 'citation': 'Buchanan AH, Datta SK, Skinner CS, Hollowell GP, Beresford HF, Freeland T, Rogers B, Boling J, Marcom PK, Adams MB. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance. J Genet Couns. 2015 Dec;24(6):961-70. doi: 10.1007/s10897-015-9836-6. Epub 2015 Apr 3.'}], 'seeAlsoLinks': [{'url': 'http://www.dukehealth.org/Services/HereditaryCancer/index', 'label': 'Duke Hereditary Cancer Clinic website'}, {'url': 'http://www.cancer.duke.edu/don/', 'label': 'Duke Oncology Network website'}]}, 'descriptionModule': {'briefSummary': 'Cancer genetic counseling (CGC) has been found to have "substantial" benefits for individuals with breast cancer and their family members; it has been deemed by multiple organizations as "standard of care" for women with breast cancer and their relatives. Unfortunately, there is a disparity in access to CGC, especially among women who live in rural and underserved areas. In North Carolina, only two cancer genetic counselors practice in rural clinics - each only for a few days per month. Therefore, in an effort to make CGC more widely available in a timely manner, we propose to test provision of counseling through telemedicine (TM), in which a patient and health care provider communicate with each other using videoconferencing. In 4 rural oncology clinics, we will implement low-cost TM and compare satisfaction and cost-effectiveness between groups of women designated to have their CGC session by TM or FTF. We\'ll use a validated measure to assess satisfaction by a phone survey one week after the CGC appointment; cost-effectiveness will be measured at project\'s end by calculating length of wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals referred for cancer genetic counseling (e.g., by medical oncologist, primary care physician or self) in one of 4 oncology clinics: Gibson Cancer Center in Lumberton, NC; Scotland Cancer Treatment Center in Laurinburg, NC; Johnston Cancer Center in Smithfield, NC; and Maria Parham Cancer Center in Henderson, NC.\n* Willing to be randomized to receive counseling via telemedicine or face-to-face.\n\nExclusion Criteria:\n\n* Referred for cancer genetic counseling from any clinic other than the 4 listed above.\n* Unwilling to be randomized to receive counseling via telemedicine or face-to-face.'}, 'identificationModule': {'nctId': 'NCT00609505', 'briefTitle': 'Telemedicine vs. Face-to-Face Cancer Genetic Counseling', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics', 'orgStudyIdInfo': {'id': 'Pro00001547'}, 'secondaryIdInfos': [{'id': 'DISP0707781'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TM', 'description': 'Telemedicine genetic counseling group', 'interventionNames': ['Other: Telemedicine']}, {'type': 'OTHER', 'label': 'FTF', 'description': 'Face-to-face genetic counseling group', 'interventionNames': ['Other: Face-to-Face']}], 'interventions': [{'name': 'Telemedicine', 'type': 'OTHER', 'description': 'Telemedicine genetic counseling', 'armGroupLabels': ['TM']}, {'name': 'Face-to-Face', 'type': 'OTHER', 'description': 'Face-to-face genetic counseling', 'armGroupLabels': ['FTF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27536', 'city': 'Henderson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Maria Parham Medical Center', 'geoPoint': {'lat': 36.32959, 'lon': -78.39916}}, {'zip': '28352', 'city': 'Laurinburg', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Scotland Cancer Treatment Center', 'geoPoint': {'lat': 34.77405, 'lon': -79.46282}}, {'zip': '28358', 'city': 'Lumberton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Gibson Cancer Center', 'geoPoint': {'lat': 34.61834, 'lon': -79.01045}}, {'zip': '27577', 'city': 'Smithfield', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Johnston Cancer Center', 'geoPoint': {'lat': 35.50849, 'lon': -78.33945}}], 'overallOfficials': [{'name': 'Martha B Adams, M.D., M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}