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Study Summary
No. 2010-0558:.......Breast......Patricia A. Parker......Behavioral Science
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Study Summary Title
Study Summary
Number:		2010-0558
Study Title:A decision-making framework for the surgical management of patients with breast cancer
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Physician New Patient Referral
Name:Patricia A. ParkerPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-0919
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:NCI
Phase of Study:N/AReturn
Visit:
Treatment
Agents:		 NoneHome Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:		The goal of this research study is to learn more about the psychological and
social characteristics related to making decisions about surgery in women with
breast cancer. Researchers want to use what is learned from this study to help
patients with breast cancer to be more informed when making decisions about
surgery with their health care providers.
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Study Objectives / Outcomes
We will prospectively evaluate the psychosocial characteristics and decision making process of women with sporadic breast cancer considering contralateral prophylactic mastectomy (CPM). The primary psychosocial factors that will be assessed include cancer-specific distress, cancer worry, fear of recurrence, knowledge about efficacy of breast cancer treatments, perceptions of risk, illness uncertainty, trust in the physician and body image. To further inform data collected through validated measures, we will also conduct qualitative interviews with a subset of women to obtain information about their treatment decision making and preferences regarding CPM.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:02/18/2011
Study Type:Behavioral
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) DCIS or Stage I-III newly diagnosed unilateral breast cancer

2) age 18 or older

3) able to speak, read, and write in English
Exclusion Criteria:1) Have had a previous breast cancer or prior history of prophylactic mastectomy

2) Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer risk (e.g., BRCA1/2, TP53)

3) And/or if they are considered at high risk for contralateral breast cancer on the basis of their family cancer history (e.g., breast cancer in multiple first-degree relatives, multiple successive generations with breast and/or ovarian cancer, mulitple family members with bilateral, pre-menopausal and/or male breast cancer)

4) Bilateral breast cancer
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Links
Registration Number: Not Applicable Clinical Trial
Other Links:
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Results

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