Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment Decisions and Breast Cancer: Psychosocial Outcomes

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contralateral Prophylactic Mastectomy (CPM) Group<br>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<br>* 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.<br>* Other names: Surveys;|
| No Contralateral Prophylactic Mastectomy (CPM) Group<br>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<br>* 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.<br>* Other names: Surveys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 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. | 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 | 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. | One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Contralateral Prophylactic Mastectomy, Questionnaires, Surveys, Psychosocial