Living Well After Breast Surgery

• ClinicalTrials.gov Identifier: NCT03834532
• Recruitment Status: Completed
• First Posted: February 8, 2019
• Last Update Posted: November 2, 2021
• Sponsor: University of Texas at Austin
• Collaborators: Ohio State University; Washington University School of Medicine
• Information provided by (Responsible Party): Michael P Pignone, University of Texas at Austin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Other: Breast reconstruction decision aid; Other: Educational website	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
• Masking: Single (Participant)
• Masking Description: Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
• Primary Purpose: Supportive Care
• Official Title: Living Well After Breast Surgery
• Actual Study Start Date: February 18, 2019
• Actual Primary Completion Date: June 11, 2021
• Actual Study Completion Date: June 11, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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.	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 Name: Web-based tool
Active Comparator: Control; 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.	Other: Educational website; The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.; Other Name: Website

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. How a patient decision aid about breast reconstruction affects knowledge about reconstruction. [ Time Frame: 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.
2. How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [ Time Frame: 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 Rating Scale.
3. How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [ Time Frame: 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 Ranking Task.
4. How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [ Time Frame: 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 Decisional Conflict Scale.
5. How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction. [ Time Frame: 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).
6. How a patient decision aid about breast reconstruction affects decision making outcomes. [ Time Frame: 6 months ]
   Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.
7. How a patient decision aid about breast reconstruction affects decision making outcomes. [ Time Frame: 6 months ]
   Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

Texas Oncology

Austin, Texas, United States, 78731

Sponsors and Collaborators

University of Texas at Austin

Ohio State University

Washington University School of Medicine

More Information

• Responsible Party: Michael P Pignone, Professor of Medicine, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03834532
• Other Study ID Numbers: 2018-05-0009
• First Posted: February 8, 2019
• Last Update Posted: November 2, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ