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Living Well After Breast Surgery

Primary Purpose

Breast Cancer Female, Stage I Breast Cancer, Stage II Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast reconstruction decision aid
Educational website
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
January 28, 2019
Last Updated
November 1, 2021
Sponsor
University of Texas at Austin
Collaborators
Ohio State University, Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03834532
Brief Title
Living Well After Breast Surgery
Official Title
Living Well After Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Ohio State University, Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Breast reconstruction decision aid
Other Intervention Name(s)
Web-based tool
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational website
Other Intervention Name(s)
Website
Intervention Description
The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
Primary Outcome Measure Information:
Title
Number of patients enrolled per month
Description
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.
Time Frame
12 months
Title
Proportion of patients retained at 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
How a patient decision aid about breast reconstruction affects knowledge about reconstruction.
Description
Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
Description
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.
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
Description
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.
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
Description
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.
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
Description
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).
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects decision making outcomes.
Description
Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.
Time Frame
6 months
Title
How a patient decision aid about breast reconstruction affects decision making outcomes.
Description
Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

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Living Well After Breast Surgery

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