Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2019-02-18
2021-06-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
Educational website
The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
Interventions
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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.
Educational website
The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult (18 years or older)
* New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS)
* Not yet had mastectomy
* Considering or planning to have mastectomy
* Able to read and speak English
* Competent to make health care decisions
Exclusion Criteria
* Age less than 18 years
* Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma
* Already had mastectomy for this diagnosis
* Planning to have breast conservation therapy
* Not being treated by a Texas Oncology surgeon or oncologist
* Not able to read and speak English
* Not competent to make health care decisions
18 Years
FEMALE
No
Sponsors
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Ohio State University
OTHER
Washington University School of Medicine
OTHER
University of Texas at Austin
OTHER
Responsible Party
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Michael P Pignone
Professor of Medicine
Locations
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Texas Oncology
Austin, Texas, United States
Countries
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Other Identifiers
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2018-05-0009
Identifier Type: -
Identifier Source: org_study_id