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OpenTrials
Completed

NCT Number: NCT03834532

Living Well After Breast Surgery

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.

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Key information

Conditions

Breast Cancer Female Adenocarcinoma Breast Carcinoma In Situ Breast Diseases 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 Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Oncology

Austin, Texas, 78731, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast reconstruction decision aid

Other

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 names: Web-based tool

Educational website

Other

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

Other names: Website

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Ohio State University
  • Washington University School of Medicine

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2019
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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