Breast Cancer
Conditions
Keywords
Breast Cancer, Contralateral Prophylactic Mastectomy, Questionnaires, Surveys, Psychosocial
Brief 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.
Detailed 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.
Interventions
BEHAVIORALQuestionnaires
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.
Sponsors
M.D. Anderson Cancer Center
Patient-Centered Outcomes Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAbenaa M. Brewster, MD, MHS, BS
M.D. Anderson Cancer Center
Participant flow
Recruitment details
Recruitment Period: February 24, 2014 to December 31, 2015. All recruitment done at The University of Texas MD Anderson and Kelsey Seybold Clinics.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 208 |
| Total | 252 |
Baseline characteristics
| Characteristic | CPM Group | No CPM Group | Total |
|---|---|---|---|
| Age, Continuous | 50.9 years | 57.4 years | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 24 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 174 Participants | 201 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 13 Participants |
| Region of Enrollment United States | 44 participants | 208 participants | 252 participants |
| Sex: Female, Male Female | 44 Participants | 208 Participants | 252 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage, Breast Cancer 0 | 25 percentage of participants | 18.4 percentage of participants | 19.4 percentage of participants |
| Stage, Breast Cancer I | 38.6 percentage of participants | 38.2 percentage of participants | 36.5 percentage of participants |
| Stage, Breast Cancer II | 27.3 percentage of participants | 38.6 percentage of participants | 36.9 percentage of participants |
| Stage, Breast Cancer III | 9.1 percentage of participants | 6.8 percentage of participants | 7.2 percentage of participants |
| Type of Surgery Bilateral mastectomy | 100 percentage of participants | 0 percentage of participants | 17.5 percentage of participants |
| Type of Surgery Breast conserving surgery | 0 percentage of participants | 67.3 percentage of participants | 55.6 percentage of participants |
| Type of Surgery Unilateral mastectomy | 0 percentage of participants | 32.7 percentage of participants | 27.0 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 208 |
| other Total, other adverse events | 0 / 44 | 0 / 208 |
| serious Total, serious adverse events | 0 / 44 | 0 / 208 |
Outcome results
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.
Time frame: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 1 Month Post-surgery | 21.84 units on a scale | Standard Error 14.58 |
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 6 Months Post-surgery | 23.43 units on a scale | Standard Error 14.69 |
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 12 Months Post-surgery | 25.3 units on a scale | Standard Error 17.26 |
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | Pre-Surgery | 29.98 units on a scale | Standard Error 16.77 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 12 Months Post-surgery | 17.01 units on a scale | Standard Error 14.79 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 6 Months Post-surgery | 18.56 units on a scale | Standard Error 16.11 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | Pre-Surgery | 24.62 units on a scale | Standard Error 16.52 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score | 1 Month Post-surgery | 19.84 units on a scale | Standard Error 14.8 |
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.
Time frame: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 1 Month assessment | 4.23 units on a scale | Standard Error 1.08 |
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 6 month assessment | 4.18 units on a scale | Standard Error 1.06 |
| CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 12 month assessment | 4.35 units on a scale | Standard Error 0.86 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 1 Month assessment | 4.27 units on a scale | Standard Error 0.81 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 6 month assessment | 4.33 units on a scale | Standard Error 0.76 |
| No CPM Group | Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision | 12 month assessment | 4.34 units on a scale | Standard Error 0.75 |