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

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05730010

Collaborator

(none)

200

Enrollment

Location

6.4

Anticipated Duration (Months)

31.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 18, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarah J Ballinger, MD, Assistant Professor of Clinical Medicine, Indiana University

ClinicalTrials.gov Identifier:

NCT05730010

Other Study ID Numbers:

CTO-IUSCCC-0803

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tarah J Ballinger, MD, Assistant Professor of Clinical Medicine, Indiana University

breast cancer, ctDNA

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Feb 15, 2023