Living Well After Breast Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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. |
Other: Breast reconstruction decision aid
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.
Other Names:
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| Active Comparator: Control 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. |
Other: Educational website
The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of patients enrolled per month [12 months]
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.
- Proportion of patients retained at 6 months [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.
Secondary Outcome Measures
- How a patient decision aid about breast reconstruction affects knowledge about reconstruction. [6 months]
Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [6 months]
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.
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [6 months]
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.
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [6 months]
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.
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [6 months]
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).
- How a patient decision aid about breast reconstruction affects decision making outcomes. [6 months]
Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.
- How a patient decision aid about breast reconstruction affects decision making outcomes. [6 months]
Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female
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Adult (18 years or older)
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New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS)
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Not yet had mastectomy
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Considering or planning to have mastectomy
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Able to read and speak English
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Competent to make health care decisions
Exclusion Criteria:
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Male
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Age less than 18 years
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Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma
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Already had mastectomy for this diagnosis
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Planning to have breast conservation therapy
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Not being treated by a Texas Oncology surgeon or oncologist
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Not able to read and speak English
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Not competent to make health care decisions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Oncology | Austin | Texas | United States | 78731 |
Sponsors and Collaborators
- University of Texas at Austin
- Ohio State University
- Washington University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-05-0009