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
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|ClinicalTrials.gov Identifier: NCT00262899|
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : January 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Behavioral: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genetic Counseling for Newly Diagnosed Breast Cancer Patients|
|Study Start Date :||August 2005|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2011|
Experimental: Rapid genetic counseling
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 Other: educational intervention Procedure: psychosocial assessment and care|
No Intervention: Usual Care
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.
- Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization [ Time Frame: 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 [ Time Frame: 1, 6, and 12 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 ]
- 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 ]
- Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262899
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Maryland|
|Chevy Chase, Maryland, United States, 20815|
|United States, New Jersey|
|Hackensack University Medical Center Cancer Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Chair:||Marc Schwartz, PhD||Lombardi Comprehensive Cancer Center|