deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02932098

Post-Operative Gynecological Oncology App Study (POGO)

Post-Op Gynecological Oncology Web-Based App Study

Sponsor: University of Tennessee

Updated 9 times since 2017 Last updated: Jun 22, 2018 Started: Aug 31, 2016 Primary completion: Jul 31, 2017 Completion: Mar 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Genital Neoplasm, Female and is currently completed. University of Tennessee leads this study, which shows 9 recorded versions since 2016 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jul 2017 · 6 months · monthly snapshotRecruiting~Jul 2017 – ~Dec 2017 · 5 months · monthly snapshotRecruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotActive Not Recruiting~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  5. Jul 2018 — Jan 2021 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting NA

  2. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  3. Jul 2017 — Dec 2017 [monthly]

    Recruiting NA

  4. Jan 2017 — Jul 2017 [monthly]

    Recruiting NA

    First recorded

Aug 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Tennessee
  • University of Tennessee West Cancer Center
Data source: University of Tennessee

For direct contact, visit the study record on ClinicalTrials.gov .