Back to resultsWeb-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Primary Purpose
Stage 0 Breast Cancer, Stage I Breast Cancer, Stage IA Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Stage 0 Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
- Rutgers Cancer Institute of New Jersey
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)
Arm II (Usual Care)
Arm Description
Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)- Decision Aid (DA).
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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
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
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.
Full Information
NCT ID
NCT03061175
First Posted
February 13, 2017
Last Updated
April 16, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03061175
Brief Title
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Official Title
Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2015 (Actual)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
April 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 0 Breast Cancer, Stage I Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (Web-Based Contralateral Prophylactic Mastectomy CPM-DA)
Arm Type
Experimental
Arm Description
Patients receive a website address, a secure username and password, and instructions for using the web-based Contralateral Prophylactic Mastectomy (CPM)- Decision Aid (DA).
Arm Title
Arm II (Usual Care)
Arm Type
Experimental
Arm Description
Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive web-based CPM-DA
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants
Description
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
Title
Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys
Description
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
Title
Decisional Conflict Assessed by the Decisional Conflict Scale
Description
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
Secondary Outcome Measure Information:
Title
Self-Efficacy at 2-4 Week Follow up Survey
Description
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
Title
Cancer Worry Assessed by 2-4 Week Follow-up Surveys
Description
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
Title
CPM Motivations Assessed by Surveys
Description
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
Title
Perceived Risk of Recurrence Assessed by 2 Items on Surveys
Description
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
Other Pre-specified Outcome Measures:
Title
User Interface Satisfaction Survey
Description
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
Title
B-Sure Use- Time
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
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