Trial Outcomes & Findings for Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM) (NCT NCT02263014)
NCT ID: NCT02263014
Last Updated: 2025-11-26
Results Overview
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.
ACTIVE_NOT_RECRUITING
345 participants
Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
2025-11-26
Participant Flow
Recruitment Period: February 24, 2014 to December 31, 2015. All recruitment done at The University of Texas MD Anderson and Kelsey Seybold Clinics.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
208
|
|
Overall Study
COMPLETED
|
44
|
208
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)
Baseline characteristics by cohort
| Measure |
CPM Group
n=44 Participants
CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery.
|
No CPM Group
n=208 Participants
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.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
n=492 Participants
|
57.4 years
n=492 Participants
|
56 years
n=984 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=492 Participants
|
208 Participants
n=492 Participants
|
252 Participants
n=984 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=492 Participants
|
24 Participants
n=492 Participants
|
38 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=492 Participants
|
174 Participants
n=492 Participants
|
201 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=492 Participants
|
10 Participants
n=492 Participants
|
13 Participants
n=984 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=492 Participants
|
208 participants
n=492 Participants
|
252 participants
n=984 Participants
|
|
Stage, Breast Cancer
0
|
25 percentage of participants
n=492 Participants
|
18.4 percentage of participants
n=492 Participants
|
19.4 percentage of participants
n=984 Participants
|
|
Stage, Breast Cancer
I
|
38.6 percentage of participants
n=492 Participants
|
38.2 percentage of participants
n=492 Participants
|
36.5 percentage of participants
n=984 Participants
|
|
Stage, Breast Cancer
II
|
27.3 percentage of participants
n=492 Participants
|
38.6 percentage of participants
n=492 Participants
|
36.9 percentage of participants
n=984 Participants
|
|
Stage, Breast Cancer
III
|
9.1 percentage of participants
n=492 Participants
|
6.8 percentage of participants
n=492 Participants
|
7.2 percentage of participants
n=984 Participants
|
|
Type of Surgery
Bilateral mastectomy
|
100 percentage of participants
n=492 Participants
|
0 percentage of participants
n=492 Participants
|
17.5 percentage of participants
n=984 Participants
|
|
Type of Surgery
Unilateral mastectomy
|
0 percentage of participants
n=492 Participants
|
32.7 percentage of participants
n=492 Participants
|
27.0 percentage of participants
n=984 Participants
|
|
Type of Surgery
Breast conserving surgery
|
0 percentage of participants
n=492 Participants
|
67.3 percentage of participants
n=492 Participants
|
55.6 percentage of participants
n=984 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
No CPM Group
n=208 Participants
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.
|
CPM Group
n=42 Participants
CPM along with scheduled mastectomy. Questionnaires completed at baseline (pre-surgery) and at 1, 6, and 12 months post-surgery.
|
|---|---|---|
|
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
Pre-Surgery
|
24.62 units on a scale
Standard Error 16.52
|
29.98 units on a scale
Standard Error 16.77
|
|
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
1 Month Post-surgery
|
19.84 units on a scale
Standard Error 14.8
|
21.84 units on a scale
Standard Error 14.58
|
|
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
6 Months Post-surgery
|
18.56 units on a scale
Standard Error 16.11
|
23.43 units on a scale
Standard Error 14.69
|
|
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
12 Months Post-surgery
|
17.01 units on a scale
Standard Error 14.79
|
25.3 units on a scale
Standard Error 17.26
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
No CPM Group
n=208 Participants
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.
|
CPM Group
n=42 Participants
CPM along with scheduled mastectomy. Questionnaires completed at baseline (pre-surgery) and at 1, 6, and 12 months post-surgery.
|
|---|---|---|
|
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
12 month assessment
|
4.34 units on a scale
Standard Error 0.75
|
4.35 units on a scale
Standard Error 0.86
|
|
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
1 Month assessment
|
4.27 units on a scale
Standard Error 0.81
|
4.23 units on a scale
Standard Error 1.08
|
|
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
6 month assessment
|
4.33 units on a scale
Standard Error 0.76
|
4.18 units on a scale
Standard Error 1.06
|
Adverse Events
CPM Group
No CPM Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Abenaa Brewster, Professor, Clinical Cancer Prevention
The University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place