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NCT05290402 Clinical Trial

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

Breast Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05290402
Other study ID # 2021-1211
Secondary ID NCI-2022-01986
Status Recruiting
Phase
First received
Last updated
Start date February 28, 2022
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Jaime Crow
Phone 713-792-6443
Email jrcrow@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• JEEVA (new digital health navigator app)
An app can be used on a mobile phone or tablet.

Locations
Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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