An interventional study of Telephone Genetic Counseling and Usual Care in Breast Cancer, sponsored by Georgetown University. Completed at 4 sites in United States. Open to female participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Georgetown University · Not applicable, Interventional, and Supportive care
RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.
After completion of genetic counseling, all participants are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 669 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Participants randomized to this arm will receive all genetic counseling via telephone.
Behavioral: Telephone Genetic Counseling
Participants randomized to usual care will receive standard in-person genetic counseling.
Behavioral: Usual Care
Participants will receive all genetic counseling via telephone
subjects will receive standard in-person genetic counseling
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
Time frame: 6 months
Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months
Time frame: 3 months
Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months
Time frame: 3 months
Quality of life as assessed by SF-12 health survey at 3 and 6 months
Time frame: 6 months
Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months
Time frame: 6 months
Costs by cost measurement post-counseling
Time frame: 6 months
Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months
Time frame: 12 months
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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