Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-10 @ 9:16 PM
Study NCT ID:
NCT00685256
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2008-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}], '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'}, {'id': 'D010051', 'term': 'Ovarian 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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2008-05-24', 'studyFirstSubmitQcDate': '2008-05-24', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported outcomes at 1-and 6-months', 'timeFrame': '6 months'}, {'measure': 'Decision conflict, as assessed by the Decisional Conflict Scale', 'timeFrame': '6 months'}, {'measure': "Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale", 'timeFrame': '6 months'}, {'measure': 'Decision quality', 'timeFrame': '6 months'}, {'measure': 'Disclosure of genetic testing results by parents', 'timeFrame': '6 months'}, {'measure': 'Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling', 'timeFrame': '6 months'}, {'measure': 'Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling', 'timeFrame': '6 months'}, {'measure': 'Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling', 'timeFrame': '6 months'}, {'measure': "Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling", 'timeFrame': '6 months'}, {'measure': "Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children", 'timeFrame': '6 months'}, {'measure': "Parents' preferences and values regarding family communication of genetic test results", 'timeFrame': '6 months'}, {'measure': 'Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale', 'timeFrame': '6 months'}, {'measure': 'Cognitive appraisals', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'hereditary breast/ovarian cancer (BRCA1, BRCA2)'], 'conditions': ['Breast Cancer', 'Hereditary Breast/Ovarian Cancer (brca1, brca2)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children.\n\nPURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.\n\nSecondary\n\n* To understand the mechanisms by which decision support impacts on decision outcomes.\n* To identify mothers who are most and least likely to benefit from decision support.\n* To explore the potential impact of decision support on disclosure and parent-child psychosocial well-being.\n\nOUTLINE: This is a multicenter study. Mothers are stratified according to their child\'s age (\\< 13 vs ≥ 13 years old), child\'s gender (female vs male), and trial site. Mothers are randomized to 1 of 2 arms.\n\n* Arm I (standard genetic counseling with communication aid): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "My Children, My Test Results," a detailed decision guide developed to promote quality and informed decision making and outcomes, and provide support to mothers regardless of whether or not they choose to communicate their BRCA1/2 test results to their children.\n* Arm II (standard genetic counseling alone): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "Genetic Testing for Breast and Ovarian Cancer Risk: It\'s Your Choice" containing information regarding family history of breast and ovarian cancer risks, BRCA1/2 genes, risks and benefits of genetic testing, medical management options for carriers, and considerations including family communication.\n\nAll mothers complete extensive family history assessments during their baseline interviews and disclose if they have been diagnosed with cancer, length and type of treatments, and the number of other relatives with a history of cancer. Mothers are assessed at baseline (pre-test genetic counseling), post-genetic counseling after learning test results, and at 1 and 6 months post-genetic counseling by a 30-45 minute multi-item and multi-scale self-report telephone survey. Genetic testing results are also submitted to this study. The frequency (number), intensity (length in minutes), and content of participant-initiated telephone contacts to genetic counselors to assess intervention reactivity; participants\' self-reported use of educational guides; and their satisfaction with the intervention will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old)\n* Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations\n* Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months\n\nPATIENT CHARACTERISTICS:\n\n* At least 21 years old (mothers)\n* No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent\n* Must be able to adequately understand, speak, and read English\n* Must have ready and consistent access to a telephone\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00685256', 'briefTitle': 'Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children', 'orgStudyIdInfo': {'id': 'CDR0000592726'}, 'secondaryIdInfos': [{'id': 'R01HG002686', 'link': 'https://reporter.nih.gov/quickSearch/R01HG002686', 'type': 'NIH'}, {'id': 'P30CA051008', 'link': 'https://reporter.nih.gov/quickSearch/P30CA051008', 'type': 'NIH'}, {'id': 'GUMC-2007-444'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'counseling intervention', 'type': 'OTHER', 'description': 'subjects and parents will receive genetic counseling'}, {'name': 'educational intervention', 'type': 'OTHER', 'description': 'subjects and parents will receive education re: genetic testing'}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'surveys will be administered to subjects and parents'}, {'name': 'psychosocial assessment and care', 'type': 'BEHAVIORAL', 'description': 'psychosocial assessment and counseling will be provided'}, {'name': 'supportive care', 'type': 'BEHAVIORAL', 'description': 'parents and children will be provided with supportive care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Comprehensive Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Kenneth Tercyak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lombardi Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}