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| ID | Type | Description | Link |
|---|---|---|---|
| R01HG002686 | U.S. NIH Grant/Contract | View source | |
| P30CA051008 | U.S. NIH Grant/Contract | View source | |
| GUMC-2007-444 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Human Genome Research Institute (NHGRI) | NIH |
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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.
PURPOSE: 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.
OBJECTIVES:
Primary
Secondary
OUTLINE: 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.
All 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other | subjects and parents will receive genetic counseling | ||
| educational intervention | Other | subjects and parents will receive education re: genetic testing | ||
| survey administration | Other | surveys will be administered to subjects and parents | ||
| psychosocial assessment and care | Behavioral | psychosocial assessment and counseling will be provided | ||
| supportive care | Behavioral | parents and children will be provided with supportive care |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported outcomes at 1-and 6-months | 6 months | |
| Decision conflict, as assessed by the Decisional Conflict Scale | 6 months | |
| Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale | 6 months | |
| Decision quality | 6 months | |
| Disclosure of genetic testing results by parents | 6 months | |
| 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 | 6 months | |
| 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 | 6 months | |
| Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling | 6 months | |
| 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 | 6 months | |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Tercyak, PhD | Lombardi Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
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| Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children |
| 6 months |
| Parents' preferences and values regarding family communication of genetic test results | 6 months |
| Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale | 6 months |
| Cognitive appraisals | 6 months |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D005791 | Patient Care |
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