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Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

This study is not yet open for participant recruitment.
Verified November 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03346161
First Posted: November 17, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.

Condition Intervention Phase
Breast Cancer Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" Other: Decision tool Other: Usual Care Group - Outcome Measures Other: Decision Group - Outcome Measures Other: Demographic and Background Questions Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in percent correct on the Knowledge measure [ Time Frame: Through completion of breast consultation appointment (total participant time approximately 1 hour) ]
    To determine whether the CDT increases knowledge about their choice, the investigators will compare scores pre (prior to breast consultation appointment)- and post (after completion of breast consultation appointment)-use of the CDT using paired sample t-test or Wilcoxon's signed-rank test as appropriate.

  • Change in the Decisional Conflict SURE measure [ Time Frame: Through completion of breast consultation appointment (total participant time approximately 1 hour) ]
    To determine whether the CDT reduces uncertainty about choice. The investigators will compare the outcome scores pre (prior to breast consultation appointment)- and post (after completion of breast consultation appointment) -use of the CDT using paired sample t-test or Wilcoxon's signed-rank test as appropriate.


Estimated Enrollment: 100
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Decision Tool
-The investigators will recruit patients who are scheduled for a plastic/reconstruction consultation. Investigators will also identify patients who have completed a mastectomy, or are scheduled for one, and are considering reconstruction, but don't have an appointment with a plastic/reconstructive surgeon. A study team member will call the patient to determine their interest and ask them to come to their scheduled appointment 30 minutes early to meet a coordinator. Patients will be randomized using computer random assignment. If the patient does not have an appointment, she will schedule a convenient time to complete study procedures with research staff. Patients will interact with the decision tool. They will be asked to answer a survey. After the appointment, for those who have clinical appointments, the team will collect information about the duration of the consultation and measures of shared decision making. Patient participation time is expected to be approximately 30 minutes.
Other: Decision tool
  • Interactive web based tool
  • Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcomes
  • The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participant different pictures of breast reconstruction outcomes, and assesses patients' knowledge and preferences for reconstruction.
Other: Decision Group - Outcome Measures
  • Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects
  • Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict)
  • Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
  • Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit)
  • Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit).
Other: Demographic and Background Questions
  • Asks 15 questions
  • Age, schooling, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, and (1) question on if participant spoke to another provider about breast reconstruction decision
Active Comparator: Arm 2: Usual Care Surgical Care Booklet
-The investigators will recruit patients who are scheduled for a plastic/reconstruction consultation. The investigators will also identify patients who have completed a mastectomy, or are scheduled for one, and are considering reconstruction, but do not have an appointment with a plastic/reconstructive surgeon. A study team member will phone the patient to determine their interest and ask them to come to their scheduled appointment 30 minutes early to meet a coordinator. Patients will be randomized using computer random assignment. Patients will interact with the usual care surgical information booklet. They will be asked to answer a survey containing several questions. After the appointment, the team will collect information about the duration of the consultation and outcome measures. Patient participation time is expected to be approximately 30 minutes.
Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"
-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction
Other: Usual Care Group - Outcome Measures
  • Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects
  • Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's conflicts on surgery (it total score less than 4, indicates higher clinical significant decisional conflict)
  • Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
  • Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction
  • Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort.
Other: Demographic and Background Questions
  • Asks 15 questions
  • Age, schooling, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, and (1) question on if participant spoke to another provider about breast reconstruction decision

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Newly diagnosed breast cancer.
  • Referred to a plastic surgeon by their surgical oncologist for possible reconstruction.
  • Considering a mastectomy.
  • Does not have metastatic disease.
  • Female.
  • English-speaking.
  • At least 18 years of age.
  • Able to understand and willing to sign an IRB-approved written informed consent document.
  Contacts and Locations
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): NCT03346161


Contacts
Contact: Terence M Myckatyn, M.D. 314-996-3255 myckatyn@wustl.edu
Contact: Mary C Politi, Ph.D., MPH 314-747-1867 mpoliti@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Terence M Myckatyn, M.D.    314-996-3255    myckatyn@wustl.edu   
Contact: Mary C Politi, Ph.D., MPH    314-747-1867    mpoliti@wustl.edu   
Principal Investigator: Terence M Myckatyn, M.D.         
Principal Investigator: Mary C Politi, Ph.D., MPH         
Sub-Investigator: Margaret Olsen, M.D., MPH         
Sub-Investigator: Rajiv Parikh, M.D., MPHS         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Terence M Myckatyn, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03346161     History of Changes
Other Study ID Numbers: 201701045
First Submitted: November 1, 2017
First Posted: November 17, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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