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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05290402
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast	Other: JEEVA (new digital health navigator app)

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)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
an application-based digital navigator 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.	Other: JEEVA (new digital health navigator app); An app can be used on a mobile phone or tablet.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Matthew Piotrowski, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05290402
• Other Study ID Numbers: 2021-1211
• First Posted: Mar 22, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 22, 2022