Trial Outcomes & Findings for Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy (NCT NCT03061175)
NCT ID: NCT03061175
Last Updated: 2021-04-20
Results Overview
CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.
COMPLETED
NA
94 participants
2-4 week follow up
2021-04-20
Participant Flow
Participant milestones
| Measure |
Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)
Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)-Decision Aid (DA).
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
Patients undergo usual care available to patients considering Contralateral Prophylactic Mastectomy (CPM) and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Baseline
STARTED
|
47
|
47
|
|
Baseline
COMPLETED
|
46
|
47
|
|
Baseline
NOT COMPLETED
|
1
|
0
|
|
Followup 1 at 2-4 Weeks Post-surgery
STARTED
|
45
|
47
|
|
Followup 1 at 2-4 Weeks Post-surgery
COMPLETED
|
39
|
44
|
|
Followup 1 at 2-4 Weeks Post-surgery
NOT COMPLETED
|
6
|
3
|
|
Followup 2 at 6 Months
STARTED
|
45
|
46
|
|
Followup 2 at 6 Months
COMPLETED
|
41
|
39
|
|
Followup 2 at 6 Months
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)
Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)-Decision Aid (DA).
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
Patients undergo usual care available to patients considering Contralateral Prophylactic Mastectomy (CPM) and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Baseline
Participant was deemed ineligible
|
1
|
0
|
|
Followup 1 at 2-4 Weeks Post-surgery
Skipped assessment
|
6
|
2
|
|
Followup 1 at 2-4 Weeks Post-surgery
Withdrawal by Subject
|
0
|
1
|
|
Followup 2 at 6 Months
Lost to Follow-up
|
4
|
7
|
Baseline Characteristics
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Baseline characteristics by cohort
| Measure |
Arm I (Web-Based CPM-DA)
n=46 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=47 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
45.5 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 8.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Education
High school
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Education
Some college
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Education
Tech or trade school
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Education
College Graduate
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Education
Some Graduate Work
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Education
Graduate Degree
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Recruitment Site
MSKCC
|
36 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Recruitment Site
MGH
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Marital Status
Married
|
38 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Marital Status
Single
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Marital Status
Divorced/Widowed
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Employment Status
Full Time
|
28 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Employment Status
Part Time
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Employment Status
On Leave
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Employment Status
Does not work
|
5 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Income
< $60,000
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Income
$60,000-$139,999
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Income
$140,000-$179,999
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Income
>$180,000
|
14 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Income
missing
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2-4 week follow upCPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants
|
62.47 score on a scale
Standard Error 3.40
|
51.33 score on a scale
Standard Error 3.24
|
PRIMARY outcome
Timeframe: 2-4 week follow upPreparedness for the CPM decision was assessed using a 16-item scale adapted from the Ottawa Preparation for Decision Making scale modified to address the CPM decision. Items evaluated the amount of and satisfaction with information about CPM. Scores were reported as a mean across the items and ranged from 1-4 with 1 = Strongly Disagree; 2= Moderately Disagree; 3 = Moderately Agree; 4= Strongly Agree Higher scores = more prepared. Outcomes reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys
|
3.46 score on a scale
Standard Error .09
|
3.42 score on a scale
Standard Error .08
|
PRIMARY outcome
Timeframe: 2-4 week follow upThe Ottawa Decisional Conflict scale has 16 items and five subscales: support for the decision, uncertainty about the decision, level of relevant information, clarity of relevant values, and effective decision. Items are rated on a 5-point Likert scale (0= Strongly Disagree to 4 = Strongly Agree). Scores for the five subscales were calculated by an average that was multiplied by 25, which is recommended by the scale's developers. Thus, scores can range from 0 (no decision conflict) to 100 (high decision conflict). Higher scores indicate more decisional conflict.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Uncertainty
|
26.38 score on a scale
Standard Error 3.50
|
25.51 score on a scale
Standard Error 3.23
|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Informed
|
13.43 score on a scale
Standard Error 1.96
|
17.13 score on a scale
Standard Error 1.81
|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Values Clarity
|
15.50 score on a scale
Standard Error 2.05
|
20.76 score on a scale
Standard Error 1.90
|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Support
|
12.48 score on a scale
Standard Error 2.51
|
16.33 score on a scale
Standard Error 2.33
|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Effective Decision
|
9.65 score on a scale
Standard Error 1.90
|
12.46 score on a scale
Standard Error 1.77
|
|
Decisional Conflict Assessed by the Decisional Conflict Scale
Confidence in Decision
|
9.10 score on a scale
Standard Error 0.35
|
8.50 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: 2-4 week follow upSelf-efficacy was a 3-item measure of confidence in the ability to manage worries and uncertainty about a possible recurrence of breast cancer, concerns about future surveillance, and worries about undergoing future surveillance. Results reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions. Scores were reported as the mean across the 3 items and ranged from 1 = Not at all confident; 2 = Somewhat confident; 3 = Moderately confident; 4 = Very confident; 5 = Extremely confident. Higher scores indicate more self-efficacy.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Self-Efficacy at 2-4 Week Follow up Survey
|
4.00 score on a scale
Standard Error 0.16
|
3.85 score on a scale
Standard Error .014
|
SECONDARY outcome
Timeframe: 2-4 week follow-upWorry is measured by a single item that asks how worried the participant is about having another form of breast cancer on a four-point Likert scale 1= not at all worried and 4 = very worried. Higher scores indicate more worry. Results reported as estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Cancer Worry Assessed by 2-4 Week Follow-up Surveys
|
2.91 score on a scale
Standard Error 0.24
|
2.84 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 2-4 week follow upReasons for CPM were measured by an 11-item scale developed after a review of the qualitative and quantitative literature on motivations for CPM and interviews with women who chose or did not choose CPM. Scored were reported as a mean score across the 11 items. The scale was scored on a 1-4 scale from not at all important to Yes, extremely important and Higher score = more reasons/motivations. Outcomes reported as Estimated marginal means, standard errors, and effect size measures for usual care and B-Sure decision aid conditions
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
CPM Motivations Assessed by Surveys
|
2.77 score on a scale
Standard Error 0.12
|
2.73 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 2-4 week follow-upPerceived risk was measured by two items. One item assessed contralateral breast cancer risk risk after unilateral mastectomy and radiation. The second item assessed perceived risk for chest wall recurrence after CPM. The first item asked "Out of 100 women with early breast cancer are treated with a single mastectomy or lumpectomy and radiation, about how many will develop breast cancer in the "other breast" in the 5 years after treatment? \_\_\_ women out of 100". The second item assessed risk for chest wall recurrence after bilateral mastectomy using the same scale 2. "If 100 women with early breast cancer have both breasts removed, how many will have breast cancer come back in the chest wall area of the "other breast" in the five years after treatment?". Outcomes reported as Estimated marginal means and standard errors for usual care and B-Sure decision aid conditions of the # out of 100 that women reported.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=39 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=44 Participants
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Perceived Risk of Recurrence Assessed by 2 Items on Surveys
Risk for CBC after unilateral mastectomy/Radiation
|
6.44 score on a scale
Standard Error 1.97
|
5.10 score on a scale
Standard Error 1.98
|
|
Perceived Risk of Recurrence Assessed by 2 Items on Surveys
risk for chest wall recurrence
|
11.95 score on a scale
Standard Error 2.52
|
12.12 score on a scale
Standard Error 2.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-4 week follow upPopulation: Results provided for B-sure intervention arm only as usual care did not view or evaluate B-sure.
The scale has 27 items and four subscales: usefulness, ease of use, ease of learning, and satisfaction. Scales ranged from 1-7 with 1 being not at all or strongly disagree up to 7 being definitely or strongly agree.
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=37 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
User Interface Satisfaction Survey
Overall Evaluation
|
5.63 score on a scale
Standard Deviation 0.77
|
—
|
|
User Interface Satisfaction Survey
Usefulness
|
4.92 score on a scale
Standard Deviation 1.42
|
—
|
|
User Interface Satisfaction Survey
Ease of use
|
6.03 score on a scale
Standard Deviation 0.76
|
—
|
|
User Interface Satisfaction Survey
Ease of learning
|
6.21 score on a scale
Standard Deviation 0.96
|
—
|
|
User Interface Satisfaction Survey
Satisfaction
|
5.56 score on a scale
Standard Deviation 1.52
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-4 week follow upPopulation: Data reported is for participants in the B-Sure intervention arm only. The usual care participants did not receive the intervention.
Basic descriptive information will be gathered regarding the length of time modules are viewed. B-Sure use will be assessed by average time spent in B-Sure
Outcome measures
| Measure |
Arm I (Web-Based CPM-DA)
n=37 Participants
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
B-Sure Use- Time
|
52.68 Minutes
Interval 2.0 to 107.0
|
—
|
Adverse Events
Arm I (Web-Based CPM-DA)
Arm II (Usual Care)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Web-Based CPM-DA)
n=46 participants at risk
Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.
Internet-Based Intervention: Receive web-based CPM-DA
Survey Administration: Ancillary studies
|
Arm II (Usual Care)
n=47 participants at risk
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Survey Administration: Ancillary studies
|
|---|---|---|
|
Social circumstances
Participant reported distress to study staff
|
0.00%
0/46 • 6 Months.
For the purposes of this study, an adverse event was defined as a participant experiencing any psychological distress, as reported by the patient to the study staff.
|
2.1%
1/47 • Number of events 1 • 6 Months.
For the purposes of this study, an adverse event was defined as a participant experiencing any psychological distress, as reported by the patient to the study staff.
|
Additional Information
Dr. Sharon Manne, Associate Director, Population Science
Rutgers Cancer Institute of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place