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| Sponsor: | Lombardi Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00685256 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) |
Other: counseling intervention Other: educational intervention Other: survey administration Procedure: psychosocial assessment and care Procedure: supportive care |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Active Control |
| Official Title: | Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Chidren |
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Andrea Farkas Patenaude, PhD 617-632-3314 andrea_patenaude@dfci.harvard.edu | |
| Principal Investigator: | Kenneth Tercyak, PhD | Lombardi Cancer Research Center |
More Information
| Responsible Party: | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center ( Kenneth Tercyak ) |
| Study ID Numbers: | CDR0000592726, GUMC-2007-444 |
| Study First Received: | May 24, 2008 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00685256 History of Changes |
| Health Authority: | Unspecified |
|
breast cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) |
|
Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Breast Diseases Endocrine Gland Neoplasms |