Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer

September 12, 2023 updated by: M.D. Anderson Cancer Center

Decision Making Tool for Contralateral Prophylactic Mastectomy

This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. An online decision support tool will be field tested that provides patients facing a decision about contralateral prophylactic breast cancer (CPM) with evidence-based information about the expected incidence of contralateral breast cancer and the life expectancy benefit of CPM. The tool will be designed for use in clinical settings and viewed jointly by the patient and physician as part of a shared decision making process around CPM.

OUTLINE:

Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Abenaa M. Brewster
          • Phone Number: 713-745-4949
        • Principal Investigator:
          • Abenaa M. Brewster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer
  • Able to speak read or write English

Exclusion Criteria:

  • Patients with previous breast cancer
  • Prior history of bilateral prophylactic mastectomy
  • Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1/2) and/or they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (decision making tool)
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
Other: Questionnaire Administration
Ancillary studies
Other: Decision Aid
Use decision making tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the decision support tool
Time Frame: Up to 2 years
Patients' rating of the acceptability of the decision support tool will be assessed using questions from the Ottawa Acceptability Measures, including the clarity, amount, and balance of the information provided by the tool. Acceptability data from patients enrolled in the field test will be reported descriptively.
Up to 2 years
Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM)
Time Frame: Baseline up to 2 years
Will test for change in knowledge from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests.
Baseline up to 2 years
Reductions in decisional conflict about CPM
Time Frame: Baseline up to 2 years
Will be assessed using the Decisional Conflict Scale. Will test for reduction in decisional conflict from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests.
Baseline up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Abenaa M Brewster, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimated)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA16-0469 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-02660 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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