Post-Operative Gynecological Oncology App Study
POGO
Post-Op Gynecological Oncology Web-Based App Study
1 other identifier
interventional
22
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJune 26, 2018
October 1, 2016
11 months
October 11, 2016
June 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improve quality of life (SF-12)
The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will measure changes in quality of life from baseline and at 30-days, and compare changes between the two study arms.
30 days
Secondary Outcomes (2)
Reduce re-admission and emergency department visits to the hospital within 30-days of discharge
30 days
Activities of daily living, status 30 days after discharge
30 days
Study Arms (2)
App Notifications
EXPERIMENTALThe web-based app will be used to remind patients of discharge instructions, ask questions related to current prescription pain medication use, new symptoms, or changes in the severity of symptoms. Patients will receive reminders via text or email to use the app. Daily reminders will be sent in Week 1, every other day in Week 2, and once per week for Weeks 3-4. All participants will be followed for a minimum of 30 days and will be asked to complete a baseline survey at enrollment and a follow-up survey scheduled 30 days after hospital discharge.
Usual Care
ACTIVE COMPARATORPatients will have access to the web-based app, but will not receive reminders to use it. All participants will be followed for a minimum of 30 days and will be asked to complete a baseline survey at enrollment and a follow-up survey scheduled 30 days after hospital discharge.
Interventions
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.
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)
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.
Eligibility Criteria
You may qualify if:
- Adult female patients (age≥18)
- Diagnosed (or suspected) of ovarian, fallopian, or primary peritoneal cancer (any stage)
- Scheduled for open abdominal surgery for cancer diagnosis and/or staging during recruitment period
- Have a mobile device with a data plan or a home computer with Internet
- Have a valid email address
- Willing to complete brief symptom reports on the app in the 30 days following hospital discharge
You may not qualify if:
- Unable to communicate in English
- A concomitant diagnosis of endometrial or breast cancer
- Did not have open abdominal surgery for a hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
West Cancer Center, DESOTO, 7668 Airways Blvd.
Southaven, Mississippi, 38671, United States
West Cancer Center, MIDTOWN, 1588 Union Ave.
Memphis, Tennessee, 38104, United States
West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
Memphis, Tennessee, 38138, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilana Graetz, PhD
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2016
First Posted
October 13, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2017
Study Completion
March 1, 2018
Last Updated
June 26, 2018
Record last verified: 2016-10