Breast Cancer Clinical Trial
Official title:
Genetic Counseling for Newly Diagnosed Breast Cancer Patients
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It
is not yet known how genetic counseling or usual care influence patient treatment decisions
for breast cancer.
PURPOSE: This randomized clinical trial is studying how well genetic counseling works
compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ,
stage I, stage II, or stage IIIA breast cancer make treatment decisions.
OBJECTIVES:
- Compare the impact of rapid genetic counseling (RGC) vs usual care on the medical
decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast
cancer.
- Compare the impact of these interventions on the quality of life and psychological well
being of these patients.
- Determine baseline factors that predict who is most and least likely to benefit from
RGC in patients undergoing these interventions.
- Compare the cost per quality adjusted life year saved from a societal perspective in
patients undergoing these interventions.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating site. Patients are randomized to 1 of 2 interventional arms.
- Arm I (rapid genetic counseling): Patients undergo a 1½ hour genetic counseling session
either in person or by telephone. Patients who undergo telephone counseling receive a
booklet of visual aids and educational materials. Patient preferences and values are
assessed immediately after counseling. Some patients may undergo BRCA1/2 status
determination. Patients undergo follow-up telephone interviews at 1, 6, and 12 months.
- Arm II (usual care): Patients receive a packet of breast cancer treatment educational
materials. Patient preferences and values are assessed 2 weeks later. Patients undergo
follow-up telephone interviews as in arm I.
In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months.
After completion of the study, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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