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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA256877-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.
Participants will complete surveys approximately within 1 week of the surgical consult and approximately 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded.
Primary objectives:
Secondary Objectives:
Exploratory Objectives:
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Approximately 800 women will be recruited at 4 study sites (Weill Cornell Medicine, Yale Cancer Center, Dana-Farber Cancer Institute, Duke Cancer Institute), including network affiliate sites, over an approximate 30-month period. All sites will have a 6-month "run-in" period where patients will not be sent CONSYDER. The 6-month blocks may be extended if recruitment targets are not met. Sites will be randomized to begin delivery of CONSYDER to all newly diagnosed women, age ≤44, with Stage 0-III breast cancer as part of routine clinical care; young women will have access to the website whether or not they consent to research study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Prior to institutional crossover, participants receive care as per usual for 6 months ("run-in" period) and are not sent CONSYDER. | |
| CONSYDER decision aid | Other | Web-based breast cancer surgery decision aid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONSYDER decision aid | Other | Web-based breast cancer surgery decision aid |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) | The Decisional Conflict Scale (DCS) includes 5 subscales (uncertainty, informed, values clarity, support, effective decision). Each item is rated on a scale of 0 (strongly agree)-4 (strongly disagree). Scores range from 0-100 with higher scores indicating more decisional conflict. | pre-surgery |
| Use of CONSYDER pre-consult | Proportion of patients eligible to use CONSYDER who logged in prior to surgical consult | pre-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) | Breast cancer knowledge will be assessed using selected questions from the adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions. The number of correct responses across (out of a total of 5 items) will be summed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shoshana Rosenberg, ScD, MPH | Contact | 646-962-8041 | shr4009@med.cornell.edu | |
| Darima Dorzhieva | Contact | 646-962-8666 | dad4011@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shoshana Rosenberg, ScD, MPH | Weill Medical College of Cornell University | Principal Investigator |
| Rachel Greenup, MD, MPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
De-identified data sets will made available, by request, to outside researchers. A data use agreement may be required with participating institutions to facilitate sharing of any data sets. Data from qualitative interviews, focus groups, audio-recordings, and any data collected from clinicians/providers will not be made available due to concerns about potentially identifying information being shared.
Data will be available following publication of the primary endpoints of the study. No end date.
Requests must be made in writing to the principal investigators. A data use agreement may be required with participating institutions to facilitate sharing of any data sets.
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| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention
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| pre-surgery |
| Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) | Treatment goals and preferences have been adapted from the BCS-DQI to include preferences salient to young women. We will ask participants to mark on a scale (not important, 0-extremely important, 10) the importance of several reasons in relation to their surgical decision. Ratings for each item will be summarized (e.g., mean, median, range). | pre-surgery |
| Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form | Anxiety, as measured with the 8-item PROMIS - Anxiety - Short Form. Response options for each item range from never (1) to always (5). Raw scores range from 5-40 and T-scores range from 37.1-83.1. Higher scores indicate higher levels of anxiety. | pre-surgery and 6 months post-surgery |
| Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). | Perceived Efficacy in Patient-Physician Interactions scale (PEPPI) has 5 items. Each item is rated on a (0, not confident at all - 10, extremely confident) scale. Scores range from 0-50, with higher scores indicating greater self-efficacy. | pre-surgery |
| Decisional regret as measured by the Decision Regret Scale (DRS) | The Decision Regret Scale (DRS) includes 5 items. Each item is rated on a scale of 1 (strongly agree)-5 (strongly disagree). Scores range from 0-100 (item scores are converted by subtracting "1" from individual items and multiplying by 25). Higher scores indicate more decisional regret. | 6 months post-surgery |
| Receipt of contralateral prophylactic mastectomy | Proportion of patients who undergo contralateral prophylactic mastectomy | 6 months post-surgery |
| Fidelity of implementation of CONSYDER via patient portal email | Proportion of patients eligible to use CONSYDER who were sent an email from patient portal | pre-surgical consult |
| Use of CONSYDER post-consult | Proportion of patients who logged in to CONSYDER post-surgical consult | up to 6 months post-surgical consult |
| Frequency of CONSYDER use pre-consult | Count of the number log-ins to CONSYDER pre-consult | pre consult |
| Frequency of CONSYDER use post-consult | Count of the number log-ins to CONSYDER post-consult | up to 6 months post-surgical consult |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
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| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |