Living Well After Breast Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | February 5, 2019 |
| End Date: | July 2020 |
| Contact: | Michael P Pignone, MD, MPH |
| Email: | pignone@austin.utexas.edu |
| Phone: | 512-495-5137 |
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.
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 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.
reconstruction decision aid or an educational website on healthy living with breast cancer.
Participants will complete 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.
Inclusion Criteria:
- Female
- 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
- Seeing and planning to have mastectomy by a Texas Oncology surgeon
- Able to read and speak English
- Competent to make health care decisions
Exclusion Criteria:
- Male
- Age less than 18 years
- Diagnosis of stage IV breast cancer, phyllodes, or sarcoma
- Already had mastectomy for this diagnosis
- Planning to have breast conservation therapy
- Being treated outside of Texas Oncology group
- Not able to read and speak English
- Not competent to make health care decisions
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