Active — Not RecruitingNot Applicable

Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

United States345 participantsStarted 2014-02-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score

Timeframe: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.

Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision

Timeframe: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.

Trial details

NCT IDNCT02263014

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-10

Results submitted2017-03-14

View on ClinicalTrials.gov More Breast Cancer trials