Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ohio State University | OTHER |
| Washington University School of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.
Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer.
Participants will complete up to three surveys; a baseline survey before viewing the decision aid or website, a second survey immediately after viewing the decision aid or website, and a third survey six months after surgery. Tablets will be made available to participants at the study site through which they can complete the surveys and view the decision aid or website. Participants will have the options of viewing the decision aid or website outside of the study site, and completing the three surveys electronically or on paper.
The baseline survey and second survey will each take approximately 45 minutes for participants to complete. The third survey will take approximately 30 minutes for participants to complete.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site. |
|
| Control | Active Comparator | Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast reconstruction decision aid | Other | The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients enrolled per month | To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month. | 12 months |
| Proportion of patients retained at 6 months | To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| How a patient decision aid about breast reconstruction affects knowledge about reconstruction. | Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module. | 6 months |
| How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Oncology | Austin | Texas | 78731 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
Not provided
Not provided
Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
|
|
| Educational website | Other | The educational website contains information on healthy living with breast cancer including, physical activity and nutrition. |
|
|
Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Rating Scale. |
| 6 months |
| How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. | Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Ranking Task. | 6 months |
| How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. | Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Decisional Conflict Scale. | 6 months |
| How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. | Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by treatment outcome recorded in patient electronic health record (EHR). | 6 months |
| How a patient decision aid about breast reconstruction affects decision making outcomes. | Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale. | 6 months |
| How a patient decision aid about breast reconstruction affects decision making outcomes. | Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale. | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |