Genetic Counseling for Newly Diagnosed Breast Cancer Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Georgetown University
- Enrollment
- 331
- Locations
- 3
- Primary Endpoint
- Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Marc D Schwartz
Professor of Oncology
Georgetown University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization
Time Frame: 1, 6, and 12 months
Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization
Time Frame: 1 and 6 months
Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization
Time Frame: 1, 6, and 12 months
Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization
Time Frame: 1 month
Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization
Time Frame: 1, 6, and 12 months
Secondary Outcomes
- Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization(12 months)