NCT03834532

Living Well After Breast Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer
• Ductal Carcinoma in Situ
• Ductal Breast Carcinoma
• Lobular Breast Carcinoma

Interventions

Type	Name	Description
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	Educational website	The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.

Timeline

• Start date: 2019-02-18
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2019-02-08
• Last updated: 2021-11-02

Locations

1 site across 1 country: United States