Post-Operative Gynecological Oncology App Study

Genital Neoplasm, Female Clinical Trial

— POGO  

Official title:

Post-Op Gynecological Oncology Web-Based App Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932098
• Other study ID #: 16-04470XP R073237324
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2018

Study information

• Verified date: October 2016
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasm, Female
• Genital Neoplasms, Female

Intervention

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.
• 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)
• 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.

Locations

Country	Name	City	State
United States	West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd	Memphis	Tennessee
United States	West Cancer Center, MIDTOWN, 1588 Union Ave.	Memphis	Tennessee
United States	West Cancer Center, DESOTO, 7668 Airways Blvd.	Southaven	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	University of Tennessee West Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	30 days
Secondary	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.	30 days