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

Completed

• Conditions: Triple Negative Breast Cancer

• Registration Number: NCT05730010
• Lead Sponsor: Indiana University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Study Start: 2023-04-16
• Primary Completion: 2023-06-26
• Study Completion: 2023-06-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine whether knowledge of ctDNA negativity influences patient decision-making	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.

Secondary Outcome Measures

Name	Time	Method
Estimate at what degree of benefit a given treatment would be acceptable to patients	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.

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States