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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07371 | Other Identifier | NCI-CTRP Clinical Trials Process Registry |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Abenaa M. Brewster, MD, MHS, BS | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelsey-Seybold | Houston | Texas | 77030 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30044695 | Derived | Parker PA, Peterson SK, Shen Y, Bedrosian I, Black DM, Thompson AM, Nelson JC, DeSnyder SM, Cook RL, Hunt KK, Volk RJ, Cantor SB, Dong W, Brewster AM. Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer. J Clin Oncol. 2018 Sep 1;36(25):2630-2638. doi: 10.1200/JCO.2018.78.6442. Epub 2018 Jul 25. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Of the 345 women enrolled some were excluded from the study, 37 were determined to be ineligible for participation (reasons included BRCA1/2 carrier, no breast surgery performed, no breast surgery at institutions, metastatic disease at diagnosis) and another 56 women did not complete the required baseline (pre-surgery) assessment.
Recruitment Period: February 24, 2014 to December 31, 2015. All recruitment done at The University of Texas MD Anderson and Kelsey Seybold Clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPM Group | 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 surgery. |
| FG001 | No CPM Group | No 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPM Group | CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery. |
| BG001 | No CPM Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point. | Posted | Mean | Standard Error | units on a scale | Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery. |
Adverse event data collected up to 12 months following surgery for breast cancer.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPM Group | CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abenaa Brewster, Professor, Clinical Cancer Prevention | The University of Texas (UT) MD Anderson Cancer Center | 713-792-7734 | abrewster@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2015 | Jul 31, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Houston |
| Texas |
| 77030 |
| United States |
No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Stage, Breast Cancer | American Joint Committee on Cancer (AJCC) Breast cancer staging: Anatomic stage 0, I, II, III or IV. AJCC staging system provides strategy for grouping participants by prognosis, based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined , and an overall stage of 0, I, II, III, IV is assigned from least advanced to more advanced. | Number | percentage of participants |
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| Type of Surgery | Number | percentage of participants |
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| Primary | 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. | Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point. | Posted | Mean | Standard Error | units on a scale | One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery. |
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| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | No CPM Group | No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery. | 0 | 208 | 0 | 208 | 0 | 208 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| 6 month assessment |
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| 12 month assessment |
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