Breast Cancer Clinical Trial

Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

Summary

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.

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Full Description

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, and 12 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.

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Eligibility Criteria

Inclusion Criteria:

Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
Age 18 or older
Able to speak, read, and write English.
Spouse/Partner: Married or living with patient for a year or more
Spouse/Partner: Age 18 or older
Spouse/Partner: Able to speak, read, and write English

Exclusion Criteria:

Patients with previous breast cancer
Prior history of prophylactic mastectomy
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

345

Study ID:

NCT02263014

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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Kelsey-Seybold
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

345

Study ID:

NCT02263014

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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