- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290402
Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
An app can be used on a mobile phone or tablet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measure ease of use, interface and satisfaction with the electronic delivery of materials through the mobile health (mHealth) App Usability Questionnaire (MAUQ)
Time Frame: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Checka, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-1211
- NCI-2022-01986 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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