Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage I Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
Conditions
Brief summary
This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM). A web-based decision aid (DA) may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy.
Detailed description
PRIMARY OBJECTIVES: I. To develop a feasible web-based decision aid (DA). SECONDARY OBJECTIVES: I. To provide preliminary data on the impact of the contralateral prophylactic mastectomy (CPM)-DA on preparedness to make the CPM decision, decisional conflict, CPM knowledge, psychosocial factors, perceived risk for cancer in the healthy/breast/metastatic disease, cancer recurrence/metastasis worry, cancer distress and intention to have CPM. OUTLINE: PHASE I (PROTOTYPE DEVELOPMENT AND TESTING): Patients attend an interview and are asked questions about experiences with CPM, reasons they chose and did not choose CPM, and CPM satisfaction for 60 minutes. Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation. PHASE II (CPM-DA FEASIBILITY TRIAL): Patients are randomized to 1 of 2 arms. ARM I: Patients undergo usual care (UC) available to patients considering CPM and receive information from a medical oncologist about CPM. ARM II: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA. After completion of study treatment, patients are followed up at 2-4 weeks and 6 months.
Interventions
OTHERInternet-Based Intervention
Receive web-based CPM-DA
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation) * PHASE I: Speaks and reads English * PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome \[BReast CAncer gene (BRCA) carrier, strong family history\]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation * PHASE I: Able to provide meaningful informed consent * PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy) * PHASE II: Has home internet access * PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer * PHASE II: Speaks and reads English * PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome \[BRCA carrier, strong family history\]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation * PHASE II: Able to provide meaningful informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys | 2-4 week follow up | Preparedness 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. |
| Decisional Conflict Assessed by the Decisional Conflict Scale | 2-4 week follow up | The 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. |
| Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants | 2-4 week follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Risk of Recurrence Assessed by 2 Items on Surveys | 2-4 week follow-up | Perceived 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. |
| CPM Motivations Assessed by Surveys | 2-4 week follow up | Reasons 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 |
| Self-Efficacy at 2-4 Week Follow up Survey | 2-4 week follow up | Self-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. |
| Cancer Worry Assessed by 2-4 Week Follow-up Surveys | 2-4 week follow-up | Worry 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| User Interface Satisfaction Survey | 2-4 week follow up | 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. |
| B-Sure Use- Time | 2-4 week follow up | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Web-Based CPM-DA) 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 | 46 |
| 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 | 47 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Arm I (Web-Based CPM-DA) | Total | Arm II (Usual Care) |
|---|---|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 8.4 | 46.5 years STANDARD_DEVIATION 8.4 | 45.5 years STANDARD_DEVIATION 8.4 |
| Education College Graduate | 15 Participants | 32 Participants | 17 Participants |
| Education Graduate Degree | 18 Participants | 35 Participants | 17 Participants |
| Education High school | 2 Participants | 5 Participants | 3 Participants |
| Education Some college | 8 Participants | 14 Participants | 6 Participants |
| Education Some Graduate Work | 2 Participants | 5 Participants | 3 Participants |
| Education Tech or trade school | 1 Participants | 2 Participants | 1 Participants |
| Employment Status Does not work | 5 Participants | 16 Participants | 11 Participants |
| Employment Status Full Time | 28 Participants | 51 Participants | 23 Participants |
| Employment Status On Leave | 5 Participants | 9 Participants | 4 Participants |
| Employment Status Part Time | 8 Participants | 17 Participants | 9 Participants |
| Income $140,000-$179,999 | 5 Participants | 11 Participants | 6 Participants |
| Income >$180,000 | 14 Participants | 24 Participants | 10 Participants |
| Income < $60,000 | 7 Participants | 17 Participants | 10 Participants |
| Income $60,000-$139,999 | 17 Participants | 34 Participants | 17 Participants |
| Income missing | 3 Participants | 7 Participants | 4 Participants |
| Marital Status Divorced/Widowed | 3 Participants | 7 Participants | 4 Participants |
| Marital Status Married | 38 Participants | 74 Participants | 36 Participants |
| Marital Status Single | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 39 Participants | 74 Participants | 35 Participants |
| Recruitment Site MGH | 10 Participants | 20 Participants | 10 Participants |
| Recruitment Site MSKCC | 36 Participants | 73 Participants | 37 Participants |
| Sex: Female, Male Female | 46 Participants | 93 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 |
| other Total, other adverse events | 0 / 46 | 1 / 47 |
| serious Total, serious adverse events | 0 / 46 | 0 / 47 |
Outcome results
Primary
Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants
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.
Time frame: 2-4 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Web-Based CPM-DA) | Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants | 62.47 score on a scale | Standard Error 3.4 |
| Arm II (Usual Care) | Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants | 51.33 score on a scale | Standard Error 3.24 |
Primary
Decisional Conflict Assessed by the Decisional Conflict Scale
The 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.
Time frame: 2-4 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Confidence in Decision | 9.10 score on a scale | Standard Error 0.35 |
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Uncertainty | 26.38 score on a scale | Standard Error 3.5 |
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Informed | 13.43 score on a scale | Standard Error 1.96 |
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Values Clarity | 15.50 score on a scale | Standard Error 2.05 |
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Support | 12.48 score on a scale | Standard Error 2.51 |
| Arm I (Web-Based CPM-DA) | Decisional Conflict Assessed by the Decisional Conflict Scale | Effective Decision | 9.65 score on a scale | Standard Error 1.9 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Support | 16.33 score on a scale | Standard Error 2.33 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Confidence in Decision | 8.50 score on a scale | Standard Error 0.33 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Values Clarity | 20.76 score on a scale | Standard Error 1.9 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Uncertainty | 25.51 score on a scale | Standard Error 3.23 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Effective Decision | 12.46 score on a scale | Standard Error 1.77 |
| Arm II (Usual Care) | Decisional Conflict Assessed by the Decisional Conflict Scale | Informed | 17.13 score on a scale | Standard Error 1.81 |
Primary
Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys
Preparedness 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.
Time frame: 2-4 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Web-Based CPM-DA) | Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys | 3.46 score on a scale | Standard Error 0.09 |
| Arm II (Usual Care) | Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys | 3.42 score on a scale | Standard Error 0.08 |
Secondary
Cancer Worry Assessed by 2-4 Week Follow-up Surveys
Worry 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
Time frame: 2-4 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Web-Based CPM-DA) | Cancer Worry Assessed by 2-4 Week Follow-up Surveys | 2.91 score on a scale | Standard Error 0.24 |
| Arm II (Usual Care) | Cancer Worry Assessed by 2-4 Week Follow-up Surveys | 2.84 score on a scale | Standard Error 0.21 |
Secondary
CPM Motivations Assessed by Surveys
Reasons 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
Time frame: 2-4 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Web-Based CPM-DA) | CPM Motivations Assessed by Surveys | 2.77 score on a scale | Standard Error 0.12 |
| Arm II (Usual Care) | CPM Motivations Assessed by Surveys | 2.73 score on a scale | Standard Error 0.11 |
Secondary
Perceived Risk of Recurrence Assessed by 2 Items on Surveys
Perceived 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.
Time frame: 2-4 week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Web-Based CPM-DA) | 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 |
| Arm I (Web-Based CPM-DA) | 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 |
| Arm II (Usual Care) | Perceived Risk of Recurrence Assessed by 2 Items on Surveys | risk for chest wall recurrence | 12.12 score on a scale | Standard Error 2.26 |
| Arm II (Usual Care) | Perceived Risk of Recurrence Assessed by 2 Items on Surveys | Risk for CBC after unilateral mastectomy/Radiation | 5.10 score on a scale | Standard Error 1.98 |
Secondary
Self-Efficacy at 2-4 Week Follow up Survey
Self-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.
Time frame: 2-4 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Web-Based CPM-DA) | Self-Efficacy at 2-4 Week Follow up Survey | 4.00 score on a scale | Standard Error 0.16 |
| Arm II (Usual Care) | Self-Efficacy at 2-4 Week Follow up Survey | 3.85 score on a scale | Standard Error 0.014 |
Other Pre-specified
B-Sure Use- Time
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
Time frame: 2-4 week follow up
Population: Data reported is for participants in the B-Sure intervention arm only. The usual care participants did not receive the intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Web-Based CPM-DA) | B-Sure Use- Time | 52.68 Minutes |
Other Pre-specified
User Interface Satisfaction Survey
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.
Time frame: 2-4 week follow up
Population: Results provided for B-sure intervention arm only as usual care did not view or evaluate B-sure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Web-Based CPM-DA) | User Interface Satisfaction Survey | Overall Evaluation | 5.63 score on a scale | Standard Deviation 0.77 |
| Arm I (Web-Based CPM-DA) | User Interface Satisfaction Survey | Usefulness | 4.92 score on a scale | Standard Deviation 1.42 |
| Arm I (Web-Based CPM-DA) | User Interface Satisfaction Survey | Ease of use | 6.03 score on a scale | Standard Deviation 0.76 |
| Arm I (Web-Based CPM-DA) | User Interface Satisfaction Survey | Ease of learning | 6.21 score on a scale | Standard Deviation 0.96 |
| Arm I (Web-Based CPM-DA) | User Interface Satisfaction Survey | Satisfaction | 5.56 score on a scale | Standard Deviation 1.52 |