Clinical trial NCT02932098: Post-Operative Gynecological Oncology App Study
Official title: Post-Op Gynecological Oncology Web-Based App Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Neoplasm, Female
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: University of Tennessee West Cancer Center
First posted: 2016-10-13
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improve quality of life (SF-12)
timeFrame: 30 days
Secondary outcomes:
measure: Reduce re-admission and emergency department visits to the hospital within 30-days of discharge
timeFrame: 30 days
measure: Activities of daily living, status 30 days after discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Southaven
country: United States
facility: West Cancer Center, DESOTO, 7668 Airways Blvd.
state: Mississippi
city: Memphis
country: United States
facility: West Cancer Center, MIDTOWN, 1588 Union Ave.
state: Tennessee
city: Memphis
country: United States
facility: West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Ilana Graetz, PhD
role: PRINCIPAL_INVESTIGATOR
References: