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Living Well After Breast Surgery

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ClinicalTrials.gov Identifier: NCT03834532
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Ohio State University
Washington University School of Medicine
Information provided by (Responsible Party):
Michael P Pignone, 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.

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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 will 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 will complete a third survey six months after surgery.
Primary Purpose: Supportive Care
Official Title: Living Well After Breast Surgery
Estimated Study Start Date : February 5, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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
  • Seeing and planning to have mastectomy by a Texas Oncology surgeon
  • 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, phyllodes, or sarcoma
  • Already had mastectomy for this diagnosis
  • Planning to have breast conservation therapy
  • Being treated outside of Texas Oncology group
  • Not able to read and speak English
  • Not competent to make health care decisions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834532


Contacts
Contact: Michael P Pignone, MD, MPH 512-495-5137 pignone@austin.utexas.edu

Locations
United States, Texas
Texas Oncology Recruiting
Austin, Texas, United States, 78731
Contact: Debra Patt, MD, MPH, MBA    512-427-9400      
Sponsors and Collaborators
University of Texas at Austin
Ohio State University
Washington University School of Medicine

Responsible Party: Michael P Pignone, Professor of Medicine, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03834532     History of Changes
Other Study ID Numbers: 2018-05-0009
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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