Post-Operative Gynecological Oncology App Study

Summary

Purpose: The purpose of this study will be to test the use of a web-based mobile application (app) initiated at the time of hospital discharge to engage and monitor patients in order to efficiently deliver better outcomes. The mobile app will be used to remind patients of discharge instructions, assess adherence treatment regimens, and evaluate symptoms.

Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a 50% increase in one-year mortality rates and significantly increased costs of care. In addition, many of the conditions and complications that led to readmission could potentially have been avoided with more intensive post-surgical follow-up care. Mobile health technologies can effectively and efficiently connect patients with their healthcare team and have been shown to improve treatment adherence and reduce avoidable ER visits and hospitalizations.

Conditions

• Genital Neoplasm, Female

Interventions

BEHAVIORAL

Discharge instructions reminders

Week 1, Day 1: Click through each discharge instruction; Week 1, Days 2-7: Click through single list of all discharge instructions. Participants will receive a reminder of discharge instructions everyday for the first week post-discharge.

BEHAVIORAL

Prompts to report symptoms via the web-enabled app

Group will receive reminders to enter new symptoms or changes in symptoms (based on a Likert scale or Y/N) on the following schedule: Week 1 (daily), Week 2 (every other day), Weeks 3-4 (once per week)

BEHAVIORAL

Clinical Alerts

Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes. These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed. Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert. Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.

Sponsors & Collaborators

• University of Tennessee West Cancer Center

  collaborator OTHER

• University of Tennessee

  lead OTHER

Principal Investigators

• Ilana Graetz, PhD · University of Tennessee

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2017-07-31

Completion

2018-03-31

Countries

• United States

Study Locations