Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genetic Counseling for Newly Diagnosed Breast Cancer Patients

Conditions
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Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Behavioral: counseling intervention
* Other: educational intervention
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed breast cancer, meeting 1 of the following criteria: Stage 0 disease (ductal carcinoma in situ only) Stage I-IIIA disease Must meet 1 of the following criteria: Diagnosis before 50 years of age Diagnosis after 50 years of age AND has 1 of the following: First or second degree relative diagnosed with breast cancer before 50 years of age First or second degree relative diagnosed with ovarian cancer at any age First or second degree relative diagnosed with male breast cancer at any age Must not have initiated definitive treatment for breast cancer No bilateral, metastatic, or inflammatory breast cancer No prior BRCA1/2 counseling or testing No prior diagnosis of metastatic cancer of any type Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Surgery No prior bilateral mastectomy for breast cancer Other No concurrent treatment for cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid genetic counseling<br>Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC. | Behavioral: counseling intervention<br> <br> Other: educational intervention<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| No Intervention: Usual Care<br>Usual Care (UC) for newly diagnosed breast cancer patients does not typically include a pre-surgical genetic referral. These patients may obtain genetic counseling at their own discretion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization |  | 1, 6, and 12 months | 
| Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization |  | 1, 6, and 12 months | 
| Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization |  | 1, 6, and 12 months | 
| Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization |  | 1 month | 
| Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization |  | 1 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer