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Post-Operative Gynecological Oncology App Study (POGO)

Primary Purpose

Genital Neoplasm, Female

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discharge instructions reminders
Prompts to report symptoms via the web-enabled app
Clinical Alerts
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Genital Neoplasm, Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult female patients (age≥18)
  2. Diagnosed (or suspected) of ovarian, fallopian, or primary peritoneal cancer (any stage)
  3. Scheduled for open abdominal surgery for cancer diagnosis and/or staging during recruitment period
  4. Have a mobile device with a data plan or a home computer with Internet
  5. Have a valid email address
  6. Willing to complete brief symptom reports on the app in the 30 days following hospital discharge

Exclusion Criteria:

  1. Unable to communicate in English
  2. A concomitant diagnosis of endometrial or breast cancer
  3. Did not have open abdominal surgery for a hysterectomy

Sites / Locations

  • West Cancer Center, DESOTO, 7668 Airways Blvd.
  • West Cancer Center, MIDTOWN, 1588 Union Ave.
  • West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

App Notifications

Usual Care

Arm Description

The 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.

Patients 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduce re-admission and emergency department visits to the hospital within 30-days of discharge
Investigators also plan to carry out a secondary analysis, which 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 any healthcare utilization within the 30 day post-discharge, and compare utilization between the two study arms.
Activities of daily living, status 30 days after discharge
Investigators also plan to carry out a secondary analysis, which 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 participants' independence 30 days post-discharge using an Activities of Daily Living (ADL) assessment adapted from the Katz Index of Independence, and compare status between the two study arms.

Full Information

First Posted
October 11, 2016
Last Updated
June 22, 2018
Sponsor
University of Tennessee
Collaborators
University of Tennessee West Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02932098
Brief Title
Post-Operative Gynecological Oncology App Study
Acronym
POGO
Official Title
Post-Op Gynecological Oncology Web-Based App Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
University of Tennessee West Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators plan to enroll 15 subjects per study arm, for a total of 30 participants. Potential subjects for recruitment will be identified from the electronic health records system of the West Cancer Center. The West Cancer Center employs four physicians specializing in gynecologic oncology who account for nearly 100% of open abdominal hysterectomies among ovarian cancer patients in the region. All four physicians have expressed strong support of the study and have agreed to actively participate by allowing screening of electronic health record data to identify appropriate patients and referral of eligible patients to the Nurse Coordinator for possible consent. The Nurse Coordinator will approach eligible patients during their surgery planning visit or in the hospital prior to surgery to provide an overview of the research study and seek informed consent. Patients who provide informed consent will immediately be asked to complete a brief baseline survey about their preferences for receiving prompts, either via email or via cell phone using a text message. After survey administration, all patients will be registered in the mobile health app, which will be used provide discharge care instructions and monitor their progress upon discharge. Study participants will then be randomized into one of two arms: 1) active prompts to use the study app or 2) use of study app, but no prompts. All participants will be followed for a minimum of 30 days and will be asked to complete a follow-up survey during a scheduled in-clinic appointment at the end of the study. Baseline and follow-up questionnaires will collect data on quality of life (SF-12), physical symptoms, activities of daily life, prescription narcotic use, health literacy, demographics and use of health care services (e.g. ER visit, hospital admission, clinic appointment). The 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. Data from this study will be derived from the following sources: electronic health data to capture treatment changes and disease severity; responses to baseline and follow-up questionnaires to measure self-reported behaviors, including quality of life, use of prescription pain medication and care utilization; and post-study semi-structured interviews with physicians and patients to provide qualitative feedback.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Neoplasm, Female

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App Notifications
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients 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.
Intervention Type
Behavioral
Intervention Name(s)
Discharge instructions reminders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prompts to report symptoms via the web-enabled app
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Clinical Alerts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improve quality of life (SF-12)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Reduce re-admission and emergency department visits to the hospital within 30-days of discharge
Description
Investigators also plan to carry out a secondary analysis, which 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 any healthcare utilization within the 30 day post-discharge, and compare utilization between the two study arms.
Time Frame
30 days
Title
Activities of daily living, status 30 days after discharge
Description
Investigators also plan to carry out a secondary analysis, which 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 participants' independence 30 days post-discharge using an Activities of Daily Living (ADL) assessment adapted from the Katz Index of Independence, and compare status between the two study arms.
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unable to communicate in English A concomitant diagnosis of endometrial or breast cancer Did not have open abdominal surgery for a hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Graetz, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Cancer Center, DESOTO, 7668 Airways Blvd.
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
West Cancer Center, MIDTOWN, 1588 Union Ave.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Post-Operative Gynecological Oncology App Study

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