Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis

August 1, 2023 updated by: Tarah J Ballinger, MD, Indiana University
This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

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

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

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

Sampling Method

Probability Sample

Study Population

Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.

Description

Inclusion Criteria:

  • Self- reported history of non-metastatic breast cancer
  • Self- reported history of receiving chemotherapy for breast cancer
  • Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago
  • Able to complete an online survey
  • English speaking

Exclusion Criteria:

N/A

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine whether knowledge of ctDNA negativity influences patient decision-making
Time Frame: Once all surveys in the sample size are completed, 6 months anticipated
Ratings- based analysis will be used to examine whether knowledge of ctDNA negativity increases patient acceptability (and if so, by how much) of no therapy in the adjuvant setting, compared to standard of care capecitabine.
Once all surveys in the sample size are completed, 6 months anticipated

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate at what degree of benefit a given treatment would be acceptable to patients
Time Frame: Once all surveys in the sample size are completed, 6 months anticipated
When assuming risk of recurrence of ctDNA positivity, we will use ratings- based conjoint analysis to determine part-worth utilities of each attribute - potential toxicity and potential benefit. Comparison of part-worth utilities will be used to estimate at what degree of benefit a given treatment would be acceptable, which will inform future trials.
Once all surveys in the sample size are completed, 6 months anticipated

Collaborators and Investigators

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

Sponsor

Indiana University

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 16, 2023

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

June 26, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0803

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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