Living Well After Breast Surgery

Not Applicable

Completed

• Conditions: Ductal Breast Carcinoma; Breast Cancer Female; Stage II Breast Cancer; Ductal Carcinoma in Situ; Stage I Breast Cancer; Stage III Breast Cancer; Lobular Breast Carcinoma
• Interventions: Other: Breast reconstruction decision aid; Other: Educational website

• Registration Number: NCT03834532
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-08
• Study Start: 2019-02-18
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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
• Considering or planning to have mastectomy
• 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, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Breast reconstruction decision aid	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.
Control	Educational website	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 treatment outcome recorded in patient electronic health record (EHR).

Trial Locations

Locations (1)

Texas Oncology; 🇺🇸 Austin, Texas, United States