Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography

This study aims to characterize patient experience, satisfaction and preference for use of the QT Scanner in comparison to mammography by directly engaging women who have experience with both technologies.

Study Overview

• Status: Suspended
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Diagnostic test: QT Scanner

Detailed Description

The objectives will be addressed by first conducting structured one-on-one interviews with about 20 women (Qualitative Phase), and then administering a web-based patient survey with quantitative measurements in about 200 women (Quantitative Phase). The current Protocol registration pertains to the first, qualitative phase of the study.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02199
      • Analysis Group, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study target population are women who have experience with both the QT Scanner and mammography.

Description

Inclusion Criteria:

• Have used the QT Scanner
• Have used mammography
• Speak English
• Willing to provide consent and participate in the survey

Exclusion Criteria:

• Excluded if all Inclusion Criteria are not met

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QT Scanner in comparison to mammography; Women who have experience with both technologies (QT Scanner/Breast mammography	Diagnostic test: QT Scanner; Diagnostic test that is repeatable, non-invasive imaging tool for the early and accurate detection of breast cancer, breast abnormalities, and musculoskeletal findings. Comparing with mammography, the QT Scanner uses harmless soundwaves to screen and diagnose the breast.; Other Names: Quantitative Transmission Ultrasound Breast Scanner-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative phase: structured one-on-one interviews	one-on-one interviews will be conducted by trained professionals with about 20 women	30 days

Collaborators and Investigators

• Sponsor: QT Ultrasound LLC
• Collaborators: Analysis Group, Inc.

Publications and helpful links

General Publications

• Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.
• Blumen H, Fitch K, Polkus V. Comparison of Treatment Costs for Breast Cancer, by Tumor Stage and Type of Service. Am Health Drug Benefits. 2016 Feb;9(1):23-32.
• Johnson FR, Zhou M. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective. Value Health. 2016 Sep-Oct;19(6):741-745. doi: 10.1016/j.jval.2016.04.008.

Helpful Links

• National Cancer Institute S, Epidemiology, and End Results Program,. Cancer Stat Facts: Female Breast Cancer.
• National Breast Cancer Foundation I. Facts about breast cancer in the United States. 2019
• American Cancer Society. Breast Cancer Facts & Figures 2017-2018.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: QT MG PRE Phase 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No