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Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery (ERAS-OncoRe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456167
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Alberta Cancer Foundation
Information provided by (Responsible Party):
Claire Temple-Oberle, Alberta Health Services, Calgary

Brief Summary:
This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient monitoring without an increase in postoperative emergency room visits, number and severity of postoperative complications, and readmissions, 3) decreased healthcare system costs, and 4) improved patient convenience and reduced patient financial costs. The study will be conducted among women having mastectomy, breast reconstruction, and gynecological oncology procedures. Half of the participants will be assigned to physician monitoring via a smartphone app and half will receive conventional care.

Condition or disease Intervention/treatment Phase
Breast Cancer Gynecologic Cancer Other: RecoverWell mobile app for follow-up care Not Applicable

Detailed Description:

ERAS® (Enhanced Recovery After Surgery) protocols are evidence-based best practices bundled together to revolutionize pre-, intra-, and postoperative care resulting in better patient outcomes, increased patient postoperative satisfaction, and decreased healthcare costs. ERAS® protocols in breast reconstruction and gynecologic oncology have been developed by surgeons from the Tom Baker Cancer Centre and have the sanction of the international ERAS® Society for implementation globally.

As of 2015, the majority of Canadians owned a cell phone. Technological advances in these forms of communications have been shown to positively impact patient experience and reduce healthcare system burdens. Telemedicine delivered healthcare via smartphone apps now include platforms for encouraging healthy behaviors, monitoring chronic healthcare conditions, organizing personal healthcare records, and monitoring postsurgical wounds.

The proposed study would marry these two advances, ERAS® protocols and smartphone technology, to consider how the combination of these two approaches to postsurgical care might enhance patient satisfaction and convenience and minimize financial burden while providing high quality care and monitoring. Additionally, the combination of these approaches has the potential to benefit the healthcare system in a number of ways. By lessening surgery-related length of stay and reducing the number of postsurgical visits, an opportunity for cost-savings is evident. In addition, in a system that is troubled by long wait-times for some procedures, reducing lengths of stay and surgeons' postoperative clinical burden means more patients can be seen and treated in a timely fashion. This is a win-win for the healthcare system and patients. It provides structure for more efficiently caring for post-operative patients in a patient first manner that supports physicians, transforms care, and engages in responsible stewardship of healthcare resources according to the Foundational Strategies developed by Alberta Health Services.

The current study would assess the patient, physician, and healthcare system impact of combining ERAS® protocol-guided oncological surgery with postsurgical patient monitoring via a smartphone app that would lessen patients' postoperative burden when postoperative recovery is uneventful and would alert physicians earlier when things are not going well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile app for follow-up care
Participants will use an app to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores daily for 2 weeks post-op & weekly for another 4 weeks. Surgeons will use a wireless interface to access that data and monitor the patient's condition. Participants will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, followup-related financial costs, and telemedicine satisfaction at 2 & 6 weeks post-op. They will attend prescribed follow-up appointments with their surgeon with the option to skip 1 or more follow-up appointments dependent on their recovery trajectory & surgeon.
Other: RecoverWell mobile app for follow-up care
The mobile app follow-up care is an application that can be loaded onto a smartphone. It allows the patient to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 6 weeks following surgery.
Other Names:
  • QoC Health Inc. mobile application
  • RecoverWell

No Intervention: Conventional inperson followup care
The conventional follow-up care group will keep to conventional follow-up schedules of all surgeons involved. They will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, and followup-related financial costs at 2 & 6 weeks post-op and attend all scheduled follow up appointments.



Primary Outcome Measures :
  1. Patient Satisfaction Questionnaire (PSQ-III) - Select Subscales [ Time Frame: 6 weeks ]
    The PSQ-III is a validated questionnaire made up of several subscales and employing a "statement of opinion" response model of 5 response categories (strongly agree, agree, uncertain, disagree, strongly disagree). The subscales being employed in the current study include general satisfaction, communication with your doctor, time spent with doctor, financial aspects, and access/availability/convenience.

  2. Quality of Recovery 15 [ Time Frame: 6 weeks ]
    The Quality of Recovery 15 scale captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).


Secondary Outcome Measures :
  1. Patient-borne Financial Costs of Followup Appointments [ Time Frame: 6 weeks ]
    The costs related to attending one or more surgical followup appointments will be tracked. Participants will maintain a log of all associated expenses.

  2. Total Number of Contacts with Medical System Postoperatively [ Time Frame: 6 weeks ]
    The total number of contacts with the healthcare system postoperatively will be tracked.

  3. Postoperative Complications [ Time Frame: 6 weeks ]
    All complications occurring within the study period will be tracked. This information will be gathered.

  4. Adverse events NCI Version 3 / EORTC [ Time Frame: 6 weeks ]
    Select adverse events including diarrhea, constipation, fever, urinary frequency/urgency, vaginal bleeding, wound complications, and fatigue will be tracked.

  5. Healthcare Professionals' Contact with Study Patients [ Time Frame: 6 weeks ]
    The participating surgeons and study nurses will keep diaries of time spent on patient followup, including followup appointments, receiving and returning phone calls, and tame spent related to virtual monitoring via the smartphone app.

  6. Healthcare Professional Response to Virtual versus Traditional FollowUp Care [ Time Frame: 6 weeks ]
    A telephone interview will be conducted with study surgeons and nursing staff at the end of the study to inquire into the impact on medical professionals conducting conventional versus virtual monitoring of postoperative patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women over 18 years of age undergoing breast reconstruction, mastectomy alone, and major gynecologic oncology procedures under ERAS protocols.
  • Must own an Android or iOS smartphone, be familiar with basic smartphone technology, be willing to install the app on their phone, to have their phone doubly-encrypted, and to learn the app and camera features of the phone as needed for the study.
  • Fluency in English

Exclusion Criteria:

  • Lack of fluency in English
  • Lack of daily access to a smartphone where the app can be installed and operated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456167


Contacts
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Contact: Carmen Webb, MA 403-521-3251 carmen.webb@ahs.ca

Locations
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Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Carmen Webb    4035213251    carmen.webb@ahs.ca   
Contact: Claire Temple-Oberle    403-521-3012    claire.temple-oberle@ahs.ca   
Principal Investigator: Claire F Temple-Oberle         
Sponsors and Collaborators
Alberta Health Services, Calgary
Alberta Cancer Foundation
Investigators
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Principal Investigator: Claire Temple-Oberle, MD MSc FRCSC University of Calgary
  Study Documents (Full-Text)

Documents provided by Claire Temple-Oberle, Alberta Health Services, Calgary:
Informed Consent Form  [PDF] March 13, 2019


Publications:
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Responsible Party: Claire Temple-Oberle, Professor, Departments of Surgery and Oncology, Alberta Health Services, Calgary
ClinicalTrials.gov Identifier: NCT03456167    
Other Study ID Numbers: TomBakerCC
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claire Temple-Oberle, Alberta Health Services, Calgary:
telemedicine
mobile applications
ERAS
postoperative care
patient satisfaction
breast reconstruction
gynecologic oncology
mastectomy