Living Well After Breast Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- University of Texas at Austin
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Number of patients enrolled per month
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Michael P Pignone
Professor of Medicine
University of Texas at Austin
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of patients enrolled per month
Time Frame: 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
Time Frame: 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 Outcomes
- How a patient decision aid about breast reconstruction affects decision making outcomes.(6 months)
- How a patient decision aid about breast reconstruction affects knowledge about reconstruction.(6 months)
- How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.(6 months)