Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:February 2014

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Treatment Decisions and Breast Cancer: Psychosocial Outcomes

The goal of this research study is to learn more about how different treatment decisions may
influence the quality of life in women with breast cancer. Researchers want to use what is
learned from this study to help future patients with breast cancer to be more informed when
making treatment decisions.

With your verbal permission, you may have been asked to complete a questionnaire about your
surgical treatment preferences for breast cancer as part of initial screening for this study.
This takes about 5 minutes to complete.

If you agree to participate in this study, during the same visit you will complete a
questionnaire about your background, such as your education level, marital status, and family
history of cancer. This should take about 3 minutes to complete.

You will also be asked to complete a questionnaire about your surgery decisions and your
feelings about those decisions at the following times: around the time you enroll in study
before your surgery, and again about 1, 6, 12, and 18 months after the surgery is completed.
This questionnaire should take about 30-40 minutes to complete each time. You may complete
this questionnaire at the clinic or you may complete it at home. If you chose to complete the
questionnaire at home, you will be given a postage-paid envelope to mail it back to the study
staff.

Length of Study:

After you complete all of the questionnaires, your participation in this study will be over.

This is an investigational study.

A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at
MD Anderson and up to 100 will take part at Kelsey-Seybold.

Inclusion Criteria:

1. Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral
invasive breast cancer

2. Age 18 or older

3. Able to speak, read, and write English.

4. Spouse/Partner: Married or living with patient for a year or more

5. Spouse/Partner: Age 18 or older

6. Spouse/Partner: Able to speak, read, and write English

Exclusion Criteria:

1. Patients with previous breast cancer

2. Prior history of prophylactic mastectomy

3. Known to have a germline gene mutation that predisposes them to an increased risk of
breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for
contralateral breast cancer on the basis of a strong family history of cancer
We found this trial at
2
sites
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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