Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients

Recruiting

• Conditions: Breast
• Interventions: Other: JEEVA (new digital health navigator app)

• Registration Number: NCT05290402
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this research study is to learn how accessible JEEVA is for patients during the perioperative period (the time after the pre-operative surgical appointment, and up to 30 days after surgery

Detailed Description

Objectives:

Demonstrate feasibility of use for a mobile device-based application to provide perioperative resources and support in a multimedia format to breast surgery patients

Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-02-28
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects eligible for this study include breast surgical patients 18 years of age and older evaluated at the Texas Medical Center campus in the Nellie B Connally breast center or in the Houston Area Locations (HALs).

This includes patients undergoing excisional biopsy, segmental mastectomy, total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, sentinel lymphadenectomy, targeted axillary lymphadenectomy, axillary lymphadenectomy, and axillary reverse mapping.

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Exclusion Criteria

Patients who do not have a smartphone), which utilizes iOS or Android operating systems,

Patients who have visual impairment or blindness, which precludes effective utilization of an app, will be excluded.

Patients whose surgical planning is discussed by telephone outside of an in-person pre-operative visit, will be excluded from the study.

Patients who have cognitive impairment will be exclude

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
an application-based digital navigator	JEEVA (new digital health navigator app)	JEEVA" is a new digital health navigator app. This app can be used on a mobile phone or tablet. JEEVA has all of the surgical teaching information from the traditional paper packet and also has additional resources like brief videos, checklists, and reference photos.

Primary Outcome Measures

Name	Time	Method
Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)	through study completion, an average of 1 year

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States