N/A
N=94
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Stage 0 Breast Cancer · Stage I Breast Cancer · Stage IA Breast Cancer · Stage IB Breast Cancer · Stage II Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03061175 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants — 62.47; 51.33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet-Based Intervention (Other); Survey Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants |
62.47; 51.33 | — |
| PRIMARY Preparedness to Make the Contralateral Prophylactic Mastectomy Decisions as Assessed by Surveys |
3.46; 3.42 | — |
| PRIMARY Decisional Conflict Assessed by the Decisional Conflict Scale |
26.38; 25.51; 13.43; 17.13; 15.50; 20.76 | — |
| SECONDARY Self-Efficacy at 2-4 Week Follow up Survey |
4.00; 3.85 | — |
| SECONDARY Cancer Worry Assessed by 2-4 Week Follow-up Surveys |
2.91; 2.84 | — |
| SECONDARY CPM Motivations Assessed by Surveys |
2.77; 2.73 | — |
| SECONDARY Perceived Risk of Recurrence Assessed by 2 Items on Surveys |
6.44; 5.10; 11.95; 12.12 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03061175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.