Living Well After Breast Surgery

Breast Cancer Female Clinical Trial

Official title:

Living Well After Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834532
• Other study ID #: 2018-05-0009
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: June 11, 2021

Study information

• Verified date: November 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Ductal Breast Carcinoma
• Ductal Carcinoma in Situ
• Lobular Breast Carcinoma
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Texas Oncology	Austin	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas at Austin	Ohio State University, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients enrolled per month	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.	12 months
Primary	Proportion of patients retained at 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.	6 months
Secondary	How a patient decision aid about breast reconstruction affects knowledge about reconstruction.	Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.	6 months
Secondary	How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.	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 Rating Scale.	6 months
Secondary	How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.	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 Ranking Task.	6 months
Secondary	How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.	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 Decisional Conflict Scale.	6 months
Secondary	How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.	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).	6 months
Secondary	How a patient decision aid about breast reconstruction affects decision making outcomes.	Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.	6 months
Secondary	How a patient decision aid about breast reconstruction affects decision making outcomes.	Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.	6 months