Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2016-08-31
2018-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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App Notifications
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.
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.
Usual Care
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. A concomitant diagnosis of endometrial or breast cancer
3. Did not have open abdominal surgery for a hysterectomy
18 Years
FEMALE
No
Sponsors
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University of Tennessee West Cancer Center
OTHER
University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Ilana Graetz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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West Cancer Center, DESOTO, 7668 Airways Blvd.
Southaven, Mississippi, United States
West Cancer Center, MIDTOWN, 1588 Union Ave.
Memphis, Tennessee, United States
West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
Memphis, Tennessee, United States
Countries
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Other Identifiers
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16-04470XP R073237324
Identifier Type: -
Identifier Source: org_study_id
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