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NCT05730010 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05730010
Other study ID # CTO-IUSCCC-0803
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2023
Est. completion date June 26, 2023

Study information
Verified date August 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 289
Est. completion date June 26, 2023
Est. primary completion date June 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Examine whether knowledge of ctDNA negativity influences patient decision-making 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 Estimate at what degree of benefit a given treatment would be acceptable to patients 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
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