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Active, not recruitingNCT02263014ClinicalTrials.gov record

Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

Breast Cancer

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
345 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Contralateral Prophylactic Mastectomy (CPM) Group

Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.

Behavioral: Questionnaires

No Contralateral Prophylactic Mastectomy (CPM) Group

Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.

Behavioral: Questionnaires

Questionnaires BEHAVIORAL

Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score

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

Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.

Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision

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

The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.

Results are posted in the registry.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Kelsey-SeyboldHouston, Texas, United StatesStatus unknown
University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesStatus unknown

Study team and timeline

Lead sponsor
M.D. Anderson Cancer Center
Study start
Feb 24, 2014 Actual
Primary completion
Oct 1, 2016 Actual
Study completion
Apr 30, 2028 Estimated
First posted
Oct 13, 2014 Estimated
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Treatment Decisions and Breast Cancer: Psychosocial Outcomes

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026